MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 8 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6720-0837
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932); Injury (2348); Reaction (2414); Metal Related Pathology (4530)
Date of Event	01/28/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
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) 2013.It is further alleged that he suffered injuries as a result of implantation of the device at issue, excessive levels of chromium and cobalt in his blood.Patient has not yet scheduled a surgery for explantation of the femoral head.
Additional Manufacturer Narrative
An event regarding altr and wear involving a accolade stem was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: "the operative report confirms a revision for trunnioninosis and altr was completed.The patient had elevated cobalt and chromium levels.The root cause of the altr cannot be determined from the limited documentation provided." -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 cobalt and chromium levels and altr.A review of the provided medical records by a clinical consultant indicated: "the operative report confirms a revision for trunnioninosis and altr was completed.The patient had elevated cobalt and chromium levels.The root cause of the altr cannot be determined from the limited documentation provided." 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.
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) 2013.It is further alleged that he suffered injuries as a result of implantation of the device at issue, excessive levels of chromium and cobalt in his blood.Patient has not yet scheduled a surgery for explantation of the femoral head.Additional information received via medical records, "there was a slightly cloudy fluid within the hip joint.There was a black crusting beneath the femoral head and at the trunnion.After cleansing the trunnion, the trunnion itself was visually damaged.Chrome cobalt levels were slightly elevated.We aspirated his hip joint of a large amount of metallosis-type fluid, which came back with elevated ion levels.".

• Brand Name: SIZE 8 ACCOLADE II 132 DEG
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7912120
• Report Number: 0002249697-2018-03094
• Device Sequence Number: 19065096
• Product Code: LPH
• UDI-Device Identifier: 04546540664518
• UDI-Public: 04546540664518
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024
• 2 Devices were Involved in the Event: 1 2

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: 09/30/2017
• Device Catalogue Number: 6720-0837
• Device Lot Number: 41466007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2012
• 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; Other; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male