MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 4.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-4535
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2016 and was revised on (b)(6) 2022.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.
Additional Manufacturer Narrative
Reported event: an event regarding wear/metallosis and abnormal ion level involving an accolade stem that was mated with an lfit v40 cocr head was reported.The wear event was confirmed via evaluation of the provided photograph of the stem and clinician review of the provided medical records.Abnormal ion level was not confirmed.Method & results: product evaluation and results: the reported device was not returned however a photograph of the stem was provided for review.Visual inspection of the provided photograph indicated that the stem is severely worn consistent with loss of taper lock.Clinician review: a review of the provided medical records by a clinical consultant indicated: "this patient underwent a primary total hip arthroplasty in 2009 and then approximately 13 years later developed elevated metal ions, metallosis and trunnion failure requiring revision.I can confirm that the patient underwent the primary and revision procedure since i was able to review the operation reports.The root cause of this event cannot be determined with certainty.Causes of elevated ion levels, trunnion failure and metallosis are multifactorial including surgical technique, patient activity level and bmi, as well as implant factors." 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.Conclusions: it was reported that the patient was revised due to elevated metal ion levels and severe wear of the stem trunnion at the stem-head junction.The reported accolade stem was mated with an lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about on (b)(6) 2016 and was revised on (b)(6) 2022.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.Update per medical records, 9/22/2023: event is for the right hip, not left."gross metal debris encountered in the hip, with black metal staining of the periprosthetic tissues.The musculature around the hip was affected including portions of the abductors.Then the prior femoral head was removed with a bone tamp.The trunnion had grossly failed and deformed and was not salvageable.A synovectomy and debridement of the periprosthetic tissues and hip joint was performed.".

• Brand Name: ACCOLADE 132 SIZE 4.5
• Common Device Name: 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15985999
• Report Number: 0002249697-2022-01832
• Device Sequence Number: 5995863
• Product Code: LPH
• UDI-Device Identifier: 04546540510631
• UDI-Public: 04546540510631
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 6020-4535
• Device Lot Number: 26302703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male