MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-0335
Medical Device Problem Codes	Corroded (1131); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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 her left hip on or about (b)(6) 2011 and was revised on (b)(6) 2022.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her blood.
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 her left hip on or about (b)(6) 2011 and was revised on (b)(6) 2022.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her blood.
Additional Manufacturer Narrative
An event regarding corrosion and abnormal ion level involving a accolade stem was reported.The event of corrosion was confirmed.Abnormal ion level was not confirmed.Method & results: product evaluation and results: material, dimensional, functional and material analysis could not be performed as the device remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: conclusion/assessment: the patient underwent a routine total hip arthroplasty in 2011.No medical records were provided for the preoperative or postoperative course.She apparently underwent revision hip arthroplasty in 2022.Again, no medical records, preoperative evaluation, radiographs or postoperative care records were provided for review.At the time of revision surgery.There were a small amount of corrosive products noted on the trunnion that were wiped free and the head and liner were exchanged.Increased metal levels were noted in the operative report but not provided for review.No laboratory studies were provided for review.This case is apparently evolved into a legal filing.Event confirmation: a primary total left hip arthroplasty in 2011 can be confirmed.A revision left hip arthroplasty in 2022 can be confirmed.Increased metal levels cannot be confirmed.Injury cannot be confirmed.Device recall cannot be confirmed.Root cause: the root cause for the total hip arthroplasty in 2011 was hip arthritis.The root cause for the revision hip arthroplasty in 2022 was stated as failed left hip arthroplasty secondary to trunnion corrosion, however corrosion products, increased metal levels, or the reasons for failure cannot be confirmed as a root cause cannot be ascertained.Product history review: a review of the device history records indicates 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: a review of the provided medical information by a clinical consultant indicated: conclusion/assessment: the patient underwent a routine total hip arthroplasty in 2011.No medical records were provided for the preoperative or postoperative course.She apparently underwent revision hip arthroplasty in 2022.Again, no medical records, preoperative evaluation, radiographs or postoperative care records were provided for review.At the time of revision surgery.There were a small amount of corrosive products noted on the trunnion that were wiped free and the head and liner were exchanged.Increased metal levels were noted in the operative report but not provided for review.No laboratory studies were provided for review.This case is apparently evolved into a legal filing.Event confirmation: a primary total left hip arthroplasty in 2011 can be confirmed.A revision left hip arthroplasty in 2022 can be confirmed.Increased metal levels cannot be confirmed.Injury cannot be confirmed.Device recall cannot be confirmed.Root cause: the root cause for the total hip arthroplasty in 2011 was hip arthritis.The root cause for the revision hip arthroplasty in 2022 was stated as failed left hip arthroplasty secondary to trunnion corrosion, however corrosion products, increased metal levels, or the reasons for failure cannot be confirmed as a root cause cannot be ascertained.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.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #3
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15542059
• Report Number: 0002249697-2022-01433
• Device Sequence Number: 6585512
• Product Code: LPH
• UDI-Device Identifier: 04546540510686
• UDI-Public: 04546540510686
• 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: 2011
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 6021-0335
• Device Lot Number: 35457402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2010
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female