MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEADS

Model Number N/A

Device Problem Misassembled (1398)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/27/2014

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive the device for investigation.Surgical reports were provided for review and will be reviewed within investigation.Where lot number were received for the device, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

Event Description

A product liability claim was raised.It was reported that the patient was implanted a biolox delta, ceramic femoral head, m, 36/0, taper 12/14 on (b)(6) 2014 on the right side and was revised on (b)(6) 2014 due to alleged mismatch of prosthetic components, instability and pain.The liner was replaced.Note: this is a splitcase with zimmer inc., (b)(4).

Manufacturer Narrative

Trend analysis: no trend identified.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Review of event description (event details, per): the patient was implanted a biolox delta ceramic head 36, taper 12/14, together with a neutral liner 32 mm on (b)(6) 2014.On (b)(6) 2014 a revision surgery due to non-compliance, instability and pain was performed.In the revision surgery the inlay was replaced.The liner is a device manufactured by zimmer inc., warsaw and is reported int the split case (b)(4).Review of received data: surgical report (b)(6) 2014: female patient, born (b)(6) 1961.Anamnestic long history with pain and difficulties of the right hip.Indication: osteoarthritis, morbid obesity (height (b)(6), weight (b)(6), bmi 44.9 = adiposity iii °), nicotine consumption (directly preoperatively stopped, patient wants to quit smoking altogether).Radiologically complete destruction of right hip joint.Therapy: hip total endoprosthesis (right) (continuum cup 54, offset stem,, ceramic head, vitamin e inlay).Intraoperative left lateral position, stepwise milling of the cup from 49 to 53, with good bleeding bone in all quadrants, insertion of the cup with superior screws, placement of a 36 id / cup 54.Good feeling and stability trial stem size 13 with larger offset, head 0.Then implantation of the components, subsequently check for good stability and good leg length.Control on (b)(6) 2014: active problems: osteoarthritis right hip, diseased overweight, obstructive sleep apnea, lymphedema of the lower extremities, anemia in acute blood loss, insomnia.Postoperative x-ray image right hip in 2 planes: normal articulation of the prosthesis, intact hardware.On the day when the patient was released from the hospital on (b)(6) 2014 the patient was well, she was stable, nonspecific documented laboratory values.Surgical report (b)(6) 2014.Replacement of the inlay on the right.Intraoperatively described hematoma after opening of the subcutaneous tissue with removal of samples for biopsy.Removing the inlay with the osteotome from the gap between the cup and the inlay.Placing an inlay with 10 ° lip anterior.Consultation report (b)(6) hospital (b)(6) 2014: in the follow-up subjectively instability feeling.After the revision surgery compared to the primary surgery more severe pain.Consultation report (b)(6) hospital (b)(6) 2014: it was determined after the operation that the patient had a "liner mismatch".The patient had instability feeling.Diagnosis: failed hip total endoprostheses.X-ray examination right hip in 2 levels, heritage hospital postop.From (b)(6) 2014: normal articulation of the prosthesis.X-ray examination right hip ap / lateral, (b)(6) hospital, (b)(6) 2014: compared to the x-ray examination of (b)(6) 2014 good alignment and position, no visible fracture or dislocation, no unexpected x-ray foreign bodies.Hospitality report (b)(6) hospital (b)(6) 2014: bmi 42.49.Legal document: (b)(6) 2014 implantation of hip endoprosthesis.(b)(6) 2014 revision surgery due to mismatch of the prosthesis components.Neither the surgeon nor the hospital staff checked whether the serial numbers on the components were matched.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the compatibility check was performed and showed that the product combination was not approved by zimmer biomet.A 36 mm head was implanted with a 32 mm liner.Root cause analysis: root cause determination using dfmea: loss of connection due to inappropriate design concerning pull-off strength (head/stem) / pull out strength (head/constrained liner) => not possible: a systematic issue with design and/or material properties would have been detected as part of a trend review.Loss of connection due to inadequate assembling procedure => possible: a compatibility check confirmed that incompatible devices were used.However, the operative notes for the primary surgery indicate that a 36 mm head was implanted with a 32 mm liner.Wrong combination of the components due to lms marking is not readable under or lighting, marking parameters are not sufficient enough => not possible: no issue noted with lms marking.Conclusion summary: it was reported that a female patient underwent revision surgery due to mismatched prosthetic components and instability.During the revision surgery, a hematoma was noted.No x-rays and no devices were received for investigation.Therefore, the condition and the position of the components are unknown.A compatibility check confirmed that incompatible devices were used.However, the operative notes for the primary surgery indicate that a 36 mm head was implanted with a 32 mm liner.Subsequently, operative notes from the revision surgery indicate that the 32 mm liner was revised and replaced with a 36 mm liner.The patient's records also state that the primary implantation was unstable and a hematoma was found during the revision surgery.A root cause for the revision is that the diameter of the liner did not match the diameter of the head.It is not known if the mismatched prosthetic components that were used in the primary surgery caused or contributed to the hematoma.With the information provided a definitive root cause for the hematoma could not be identified.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer's reference number of this file is (b)(4).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEADS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6423681
• MDR Text Key: 70516264
• Report Number: 0009613350-2017-00412
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

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: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-02
• Device Lot Number: 2738353
• Other Device ID Number: 00889024430365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 03/22/2017
• Supplement Dates Manufacturer Received: 07/12/2017
• Supplement Dates FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 134