MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-2530
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	01/14/2021
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 her right hip on or about (b)(6) 2017 and was revised on (b)(6) 2021.It is further alleged that she 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 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 right hip on or about (b)(6) 2017 and was revised on (b)(6), 2021.It is further alleged that she 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 her blood.
Additional Manufacturer Narrative
Reported event: an event regarding abnormal ion level, wear (trunnionosis) and altr involving a accolade stem was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: "review of the records confirms the index surgery was completed with a cocr v40 lfit femoral head.The surgeon in his revision operative note states that the patient had a pseudotumor and altr and believed there was evidence of trunionosis which he felt to be the cause.He performed a head revision only using a ceramic head and metal sleeve.It is confirmed that a revision tha was performed for what was thought to be trunnionosis with an altr and pseudotumor.Other than the description in the operative record no further evidence of elevated serum ion levels, altr and pseudotumor was presented.The root cause for the trunnionosis leading to these issues and the revision surgery can not be determined from the limited information available." -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 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 her blood.A review of the provided medical information by a clinical consultant indicated: "review of the records confirms the index surgery was completed with a cocr v40 lfit femoral head.The surgeon in his revision operative note states that the patient had a pseudotumor and altr and believed there was evidence of trunionosis which he felt to be the cause.He performed a head revision only using a ceramic head and metal sleeve.It is confirmed that a revision tha was performed for what was thought to be trunnionosis with an altr and pseudotumor.Other than the description in the operative record no further evidence of elevated serum ion levels, altr and pseudotumor was presented.The root cause for the trunnionosis leading to these issues and the revision surgery can not be determined from the limited information available."the exact cause of the event could not be determined because insufficient information was provided.The medical records provided for review were insufficient to confirm the reported events or determine root cause.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ACCOLADE 132 SIZE 2.5
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13790625
• Report Number: 0002249697-2022-00404
• Device Sequence Number: 4023306
• Product Code: LPH
• UDI-Device Identifier: 04546540510617
• UDI-Public: 04546540510617
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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: 12/31/2021
• Device Model Number: 6020-2530
• Device Catalogue Number: 6020-2530
• Device Lot Number: 57366505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2016
• 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 Sex: Female