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

Model Number	6020-0335
Medical Device Problem Codes	Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Discomfort (2330); Metal Related Pathology (4530)
Date of Event	01/18/2021
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.
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) 2009 and was revised on (b)(6) 2021.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.
Additional Manufacturer Narrative
Reported event: an event regarding corrosion, altr and abnormal ion level involving an accolade stem was reported.The events were confirmed through clinician review of the provided medical records.Method & results: device evaluation and results: not performed as product remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a total hip replacement over 11 years after implantation due to trunnionosis and elevated ion levels.I can confirm that this event took place since i was able to review the revision operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of trunnionosis are multifactorial including surgical technique factors, patient factors, and implant factors.Device 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 reported lot.  conclusion: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a total hip replacement over 11 years after implantation due to trunnionosis and elevated ion levels.I can confirm that this event took place since i was able to review the revision operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of trunnionosis are multifactorial including surgical technique factors, patient factors, and implant factors.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 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) 2009 and was revised on (b)(6) 2021.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.Update based on medical review dated 26 march 2022: "there was gray and tan colored synovium throughout the left hip consistent with a pseudotumor." surgeon stated that the femoral head was challenging to remove.He found ¿substantial amount of corrosion over the trunnion as well as inside of the morse taper of the femoral head.This was consistent with trunnionosis.

• Brand Name: ACCOLADE 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 13505741
• Report Number: 0002249697-2022-00209
• Device Sequence Number: 14739456
• Product Code: LPH
• UDI-Device Identifier: 04546540510556
• UDI-Public: 04546540510556
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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: 11/30/2013
• Device Model Number: 6020-0335
• Device Catalogue Number: 6020-0335
• Device Lot Number: 28251202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2008
• 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 Sex: Male