| Model Number N/A |
| Device Problems
Device Dislodged or Dislocated (2923); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)
|
| Patient Problem
No Code Available (3191)
|
| Event Date 11/03/2016 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
(b)(4).Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Concomitant medical products: device name: revision shell liner cemented 10 degree liner face angle oblique 32 mm i.D.For use with 66/68/70 mm o.D.Shell, model#: 00711006632, lot#: 62700193.Device name: trabecular metala acetabular revision shell, model#: 00700006620, lot#: 62719340.Device name: cer option type 1 tpr sleeve +6, model#: 650-1068, lot#: 3196783.Device name: unknown shell, model#: unknown, lot#: unknown.Due to fact that this is a legal claim, our legal department has been provided with the relevant facts from the customer.Further information concerning the case will be provided by the legal department to our complaint handling department as and when it becomes available.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product has not been returned.
|
| |
|
Event Description
|
|
It was reported that a patient underwent initial left total hip arthroplasty on (b)(6) 2005.Subsequently, the patient underwent three revision surgeries for periprosthetic fracture, loosening, alval, and pseudotumor.On (b)(6) 2016, the patient underwent a fourth revision due to patient reports of subluxation and instability.During the revision, it was noted that the shell was nearly vertical in position but well-fixed.A new shell, head, and liner was placed to correct the instability.This report is based on allegations set forth in patient's notice and the allegations there in are unverified.This complaint reports the hip revision due to subluxation performed on (b)(6) 2016.
|
| |
|
Event Description
|
|
It was reported that a patient underwent initial left total hip arthroplasty on (b)(6) 2005.Subsequently, the patient underwent three revision surgeries for periprosthetic fracture, loosening, alval, and pseudotumor.On (b)(6) 2016, the patient underwent a fourth revision due to patient reports of subluxation and instability.During the revision, it was noted that the shell was nearly vertical in position but well-fixed.A new shell, head, and liner was placed to correct the instability.This report is based on allegations set forth in patient's notice and the allegations there in are unverified.This complaint reports the hip revision due to subluxation performed on (b)(6) 2016.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).This follow-up report is being submitted to relay additional information.Report source, foreign - event occurred in sweden.The investigation is in process.Due to fact that this is a legal claim, our legal department has been provided with the relevant facts from the customer.Further information concerning the case will be provided by the legal department to our complaint handling department as and when it becomes available.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).Upon reviewing the complaint, it was identified that the lot number for the associated product cer option type 1 tpr sleve +6 (item number : 650-1068) is 3196763 not 3196783.D11: device name: revision shell liner cemented 10 degree liner face angle oblique 32 mm i.D.For use with 66/68/70 mm o.D.Shell, model#: 00711006632, lot#: 62700193.Device name: trabecular metalâ¿¢ acetabular revision shell, model#: 00700006620, lot#: 62719340.Device name: cer option type 1 tpr sleve +6, model#: 650-1068, lot#: 3196763.Device name: unknown shell, model#: unknown, lot#: unknown.The investigation is in process.Due to fact that this is a legal claim, our legal department has been provided with the relevant facts from the customer.Further information concerning the case will be provided by the legal department to our complaint handling department as and when it becomes available.
|
| |
|
Event Description
|
|
It was reported that a patient underwent initial left total hip arthroplasty on (b)(6) 2005.Subsequently, the patient underwent three revision surgeries for periprosthetic fracture, loosening, alval, and pseudotumor.On (b)(6) 2016, the patient underwent a fourth revision due to patient reports of subluxation and instability.During the revision, it was noted that the shell was nearly vertical in position but well-fixed.A new shell, head, and liner was placed to correct the instability.This complaint reports the hip revision due to subluxation performed on (b)(6) 2016.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Radiographs: fifteen anteroposterior full-pelvis radiographs were provided for analysis with (b)(4), the description of each x-ray listed below refers to the revision surgery on the patient left hip: x-ray 1 ¿ post-revision 1 ¿ (b)(6) 2008; x-ray 2 ¿ post-revision 1 ¿ (b)(6) 2010; x-ray 3 ¿ post-revision 1 ¿ (b)(6) 2011; x-ray 4 ¿ post-revision 2 ¿ (b)(6) 2011; x-ray 5 ¿ post-revision 2 ¿ (b)(6) 2011; x-ray 6 ¿ post-revision 2 ¿ (b)(6) 2011; x-ray 7 ¿ post-revision 2 ¿ (b)(6) 2012; x-ray 8 ¿ post-revision 2 ¿ (b)(6) 2012; x-ray 9 ¿ post-revision 2 ¿ (b)(6) 2014; x-ray 10 ¿ post-revision 3 ¿ (b)(6) 2015; x-ray 11 ¿ post-revision 3 ¿ (b)(6) 2015; x-ray 12 ¿ post-revision 3 ¿ (b)(6) 2015; x-ray 13 ¿ post-revision 3 ¿ (b)(6) 2015; x-ray 14 ¿ post-revision 3 ¿ (b)(6) 2015; x-ray 15 ¿ post-revision 3 ¿ (b)(6) 2016.(b)(4) refers to the revision surgery of the left prosthesis on (b)(6) 2016 and therefore x-rays 10-15 are relevant for this event.The patient has total joint replacements in both hips.The surgeries to the right hip, including a revision on (b)(6) 2012, will not be analysed in this assessment.The patient is female with a height of 1.63 m, weight of 100 kg and bmi of 37.6 (obese).The patient was 75 at the time of the fourth revision surgery to the left hip ((b)(6) 2016).The patient received total joint replacement on her left hip at (b)(6) hospital on (b)(6) 2005 (age 64), where all subsequent revision surgeries were also performed.According to the records, the patient had hip surgery on the right hip four months earlier and has certain leg length difference which was adjusted during the surgery on (b)(6).Two versions of the medical review form state that: a first revision surgery of the left hip was performed on (b)(6) 2005 due to a calcar periprosthetic fracture and subsidence of the femoral stem.The intraoperative report states that the patient gradually developed increasing pain, x-rays show that the prosthesis has sunken (2cm) and there is also a crack in the proximal femur; no sign of infection, femoral component rotated backwards; fracture identified and secured with cerclage wires; stem easily removed and replaced, new head placed.On (b)(6) 2011 it was noted that the cup had move position and was at a sharper angle, prosthesis was in place but suspected incipient loosening, resorption zone was noted to have increased, the patient test results had during the past months revealed elevated but stable levels which indicate infection (of the labs provided, only crp inflammatory levels were elevated.Infection unconfirmed, only suspected, therefore, not called out as complaint category), which suggests poor bone stock and a potential infection in the left hip, albeit with an inconclusive diagnosis.Laboratory results dated (b)(6) 2011 were provided.They confirm that the patient crp level was 7 mg/l, when the normal value is < 3.The patient left hip, namely the shell, liner, neck and screws, was revised a second time on (b)(6) 2011 due to pain and loosening of the acetabular shell; the femoral stem was left in place and all other components revised.The bi-metric stem was combined with an m2a head, triology shell and liner, which constitutes a case of off-label usage.Laboratory results dated (b)(6) 2012 were provided.They confirm the that the patient crp level was 16 mg/l.Findings during 2014 included xrays demonstrate pseudotumor development; alval pseudotumour; cobalt levels of 6.79, chromium 1.25.The metal ion report dated 27 november 2014, confirms these values were cobalt 6.79 ± 1.12 g/l and chromium 1.25 ± 0.41 g/l.The contribution of the patient right hip replacement to the reported metal ion levels is not known.Laboratory results dated 5 september 2014 were provided they confirm that the patient crp level was 7 mg/l.Laboratory results dated 14 january 2015 were provided.They confirm that the patient crp level was 8 mg/l.A third revision surgery due to pain, loosening, and elevated metal ions was performed on (b)(6) 2015.During that surgery, an apparent pseudotumor, alval, and necrotic tissue were debrided, and osteolysis noted.The stem remained, and all other components were revised.The following components were implanted: tmt shell 66mm, cemented poly liner, +6 ceramic head, 62mm sleeve.The trabecular metal shell (part number 00-7000-066-20) and cemented longevity liner (part number 00-7110-066-32) are zimmer products, whereas the biolox delta femoral head and biolox adapter sleeve are biomet products.Therefore, this constitutes off-label use of biomet products at the time of the surgery.A summary of the patient health history prepared by outside counsel states that according to the surgery minutes, luxation appears first at flexion and 80 degrees inwards rotation, which the doctor is satisfied with.Tissue samples revealed no inflammation but appeared to be compatible with articular cyst (reactive) with necrotic content.The patient reported recurrent pain post-revision.After the revision surgery on (b)(6) 2015, the patient revisited the hospital on several occasions with what appeared to be pneumonia, but the doctors deemed it not to be an infection in the prosthesis.Findings during 2015 included xray review demonstrates unchanged position since the surgery and no signs of loosening, deemed it not to be an infection in the prosthesis; radiology reports state that the cup has a sharp inclination and almost placed vertically, patient reports feelings of luxation and instability though not observed.Laboratory results dated (b)(6) 2015 were provided.They confirm that the patient crp level was 102 mg/l.Laboratory results dated (b)(6) 2015 were provided.They confirm that the patient crp level was 232 mg/l.The same laboratory report states a sedimentation rate of 71 mm (assumed to mean mm/hr), when the normal value is < 30.Laboratory results dated 8 july 2015 were provided.They confirm that the patient crp level was 9 mg/l.Laboratory results dated 5 august 2015 were provided.They confirm that the patient crp level was 4 mg/l.Laboratory results dated 27 october 2015 were provided.They confirm that the patient crp level was 4 mg/l.Laboratory results dated (b)(6) 2016 were provided.They confirm that the patient crp level was 5 mg/l.The same laboratory report states a sedimentation rate of 122 mm (assumed to mean mm/hr).Finally, a fourth revision surgery due to patient reports of subluxation and instability, the object of the current assessment, was performed on (b)(6) 2016.The document states malposition as one of the complaint categories.During surgery, it was noted that the shell was nearly vertical in position but well-fixed.A new shell, head, and liner was placed to correct the instability.Elsewhere in the document, it is stated that shell well-fixed, liner and head replaced, it appears that the new smaller 54mm shell was cemented into the larger 66mm pre-existing shell.This is confirmed by the list of explanted items: ref 00711006632 lot 62700193 tm longevity; liner; ref 650-1068 lot 3196783; biolox sleeve +6 neck; ref 650-1056; biolox 32mm head.Which does not include the 66 mm trabecular metal shell.The inclination angle of the trabecular metal acetabular shell prior to the fourth revision surgery was measured in six xrays dated (b)(6) 2015, 25 february 2015, (b)(6) 2015, (b)(6) 2015, (b)(6) 2015 and (b)(6) 2016 to be 74.1°, 75.7°, 77.9°, 78.4°, 81.4° and 82.4°, respectively.Furthermore, the medical metrics, inc.Maven md reviewer case report states that the left hip had vertical orientation and that the patient is likely at risk for dislocation, as a result.It also mentions that lucency surrounding the left acetabular cup most consistent with loosening.This information is in agreement with the complaint category of malposition, the patient report of luxation and instability, as well as intraoperative reports of the shell being nearly vertical.The surgical notes did however state that the shell was well-fixed during the revision procedure.Additional findings and contributing conditions: in (b)(6) 2008, it was noted that the patient had surgery on right knee; the patient was diagnosed with obesity and hypertension; the patient had aspiration of left hip/thigh, no fluid could be extracted on (b)(6) 2010.A biolox delta option 16/18 ø32 mm femoral head (part number 650-1056) and an extra large biolox 16/18-type 1 adapter sleeve (part number 650- 1068) were revised on 3rd november 2016.The manufacturing history records (mhrs) for the components have been checked and verify that they were manufactured and sterilised in accordance with the applicable specifications.It is likely that the root cause of the subluxation and instability is multifactorial; contributing factors may include the high inclination angle of the acetabular shell, suboptimal bone quality, prior revisions, the patient bmi, comorbidities and other surgeries.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaints reported with the item 650-1056.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the event reports revision due to subluxation and instability.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.The complaint summary states that the left hip had vertical orientation and that the patient is likely at risk for dislocation, as a result.The summary also states the evidence available at the time of writing this report suggests that these two components - biolox delta option (650-1056) and an extra large biolox 16/18-type 1 adapter sleeve (650-1068) - functioned as intended, however this cannot be confirmed without examination of the revised components.Risk management report documents the estimated residual risk associated with the reported event.The reported event states revision due to subluxation and instability.In the risk file, dislocation is considered harm with a severity level of 3 for a number of hazards defined as moderate, which is described in the severity table as: s-3 prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.Instability is likely caused by suboptimal bone quality, and is not related to item 650-1056.The outcome of this complaint (surgical intervention) is considered to be within the severity of the rmf.Occurrence rate has not been calculated for item biolox delta option (650-1056), as the evidence suggests it was functioning as intended.The inclination angle of the associated item (acetabular shell 00700006620), was a likely contributing factor towards the reported event of subluxation and instability.No corrective or preventive actions are deemed necessary at this time.H3 other text : product has not been returned.
|
| |
|
Event Description
|
|
It was reported that a patient underwent initial left total hip arthroplasty on (b)(6) 2005.Subsequently, the patient underwent three revision surgeries for periprosthetic fracture, loosening, alval, and pseudotumor.On (b)(6) 2016, the patient underwent a fourth revision due to patient reports of subluxation and instability.During the revision, it was noted that the shell was nearly vertical in position but well-fixed.A new shell, head, and liner was placed to correct the instability.This complaint reports the hip revision due to subluxation and instability performed on (b)(6) 2016.
|
| |
|
Search Alerts/Recalls
|
|
