MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRIT HEMI SOLIDBACK CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 500-03-52D

Device Problem Loss of Osseointegration (2408)

Patient Problems Bacterial Infection (1735); Pain (1994); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 05/03/2022

Event Type  Injury  

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lift anatomic v40 femoral head on her left hip on (b)(6) 2014.It is further alleged that the subject products malfunctioned and/or dislodged causing injuries to patient, including but not limited to elevated cobalt levels and the need for further surgery to replace the stryker implants.

Manufacturer Narrative

The following devices were also listed in this report: trident 0 deg insert 36mm; cat # 623-00-36d; lot # mnrdky.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding loosening and infection involving a trident shell was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical information by a clinical consultant indicated: "on (b)(6) 2014 the patient underwent an uncomplicated tha.She presented to her surgeon in 2022 complaining of pain.A workup was initiated and she was found to have a periprosthetic joint infection with staph epidermidis.In addition she was found to have elevated serum ions.Intra-operatively her cup was determined to be "grossly loose" while her stem was "well fixed".Upon removal of the femoral head trunnion corrosion was identified.The femoral and acetabular components were explanted the hip debrided and new components were cemented in to place.It is confirmed that a revision surgery for periprosthetic joint infection with staph epidermidis occurred.Acetabular loss of fixation and trunnion corrosion were noted.The root cause of the periprosthetic joint infection, loss of acetabular fixation and trunnion corrosion cannot be determined from the documentation provided." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.There has been 1 other similar event for the sterile lot referenced.Conclusions: it was reported that the patient was revised due to pain, acetabular loosening, infection, and elevated metal ions.Intraoperatively, corrosion at the stem-head junction was also observed.The event was confirmed via clinician review of the provided medical records: "it is confirmed that a revision surgery for periprosthetic joint infection with staph epidermidis occurred.Acetabular loss of fixation and trunnion corrosion were noted.The root cause of the periprosthetic joint infection, loss of acetabular fixation and trunnion corrosion cannot be determined from the documentation provided." a microbiological assessment was completed by a stryker microbiologist who indicated: "staphylococcus epidermidis have been identified as cause of infection of patient.Staphylococcus epidermidis, coagulase-negative staphylococci, have been considered innocuous commensals of human skin and mucous membranes but are now accepted as the leading opportunistic pathogens responsible for numerous nosocomial infections [1].In particular, they account for 30 to 43% of joint prosthesis infections [2].The current accepted pathophysiological mechanism of s.Epidermidis orthopedic device infection is the direct inoculation of skin colonizing strains at the time of surgery stryker can confirm that the origin of infection cannot have been the implants used for this hip surgery.Ultra-high-molecular-weight polyethylene (uhmwpe) plastic hip implants are gamma-irradiated between 25-35kgy for sal 10-6.Metal hip implants are gamma-irradiated between 25-45kgy for sal 10-6.Ceramic hip implants are gamma- irradiated between 25-40kgy for sal 10-6.Uhmwpe plastic x3 hip implants are subjected to overkill sterilisation cycles demonstrating sal 10-6 at half-cycle parameters.Conclusion: due to the nature of the organisms isolated ¿ susceptible to various modes of sterilisation - and the sterilisation methodology employed by stryker, it is not possible that staphylococcus epidermidis could have originated from the implants." no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Manufacturer Narrative

Reported event: an event regarding loosening and infection involving a trident shell was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical information by a clinical consultant indicated: "on (b)(6) 2014 the patient underwent an uncomplicated tha.She presented to her surgeon in 2022 complaining of pain.A workup was initiated and she was found to have a periprosthetic joint infection with staph epidermidis.In addition she was found to have elevated serum ions.Intra-operatively her cup was determined to be "grossly loose" while her stem was "well fixed".Upon removal of the femoral head trunnion corrosion was identified.The femoral and acetabular components were explanted the hip debrided and new components were cemented in to place.It is confirmed that a revision surgery for periprosthetic joint infection with staph epidermidis occurred.Acetabular loss of fixation and trunnion corrosion were noted.The root cause of the periprosthetic joint infection, loss of acetabular fixation and trunnion corrosion cannot be determined from the documentation provided." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.There has been 1 other similar event for the sterile lot referenced.Pr also relates to infection.Conclusions: it was reported that the patient was revised due to pain, acetabular loosening, infection, and elevated metal ions.Intraoperatively, corrosion at the stem-head junction was also observed.The event was confirmed via clinician review of the provided medical records: "it is confirmed that a revision surgery for periprosthetic joint infection with staph epidermidis occurred.Acetabular loss of fixation and trunnion corrosion were noted.The root cause of the periprosthetic joint infection, loss of acetabular fixation and trunnion corrosion cannot be determined from the documentation provided." a microbiological assessment was completed by a stryker microbiologist who indicated: "staphylococcus epidermidis have been identified as cause of infection of patient.Staphylococcus epidermidis, coagulase-negative staphylococci, have been considered innocuous commensals of human skin and mucous membranes but are now accepted as the leading opportunistic pathogens responsible for numerous nosocomial infections [1].In particular, they account for 30 to 43% of joint prosthesis infections [2].The current accepted pathophysiological mechanism of s.Epidermidis orthopedic device infection is the direct inoculation of skin colonizing strains at the time of surgery [2][3].Stryker can confirm that the origin of infection cannot have been the implants used for this hip surgery.Ultra-high-molecular-weight polyethylene (uhmwpe) plastic hip implants are gamma-irradiated between 25-35kgy for sal 10-6.Metal hip implants are gamma-irradiated between 25-45kgy for sal 10-6.Ceramic hip implants are gamma- irradiated between 25-40kgy for sal 10-6.Uhmwpe plastic x3 hip implants are subjected to overkill sterilisation cycles demonstrating sal 10-6 at half-cycle parameters.Conclusion: due to the nature of the organisms isolated ¿ susceptible to various modes of sterilisation - and the sterilisation methodology employed by stryker, it is not possible that staphylococcus epidermidis could have originated from the implants." no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic v40 femoral head on her left hip on (b)(6) 2014.It is further alleged that the subject products malfunctioned and/or dislodged causing injuries to patient, including but not limited to elevated cobalt levels and the need for further surgery to replace the stryker implants.Update: revision operative report indicates that the patient presented with right hip pain and a loose acetabular component.Work-up revealed elevated metal ion levels.Pre-op aspiration showed staph epidermis infection.Intraoperatively, some superior bone loss was noted around the acetabulum."clear corrosion" of the femoral trunnion was observed following removal of the femoral head.Femoral and acetabular components were revised and irrigation and excisional debridement were performed.

• Brand Name: PRIMARY TRIT HEMI SOLIDBACK CUP 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18480909
• MDR Text Key: 332491575
• Report Number: 0002249697-2024-00052
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327040043
• UDI-Public: 07613327040043
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 500-03-52D
• Device Lot Number: MNNKHL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female