MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-5537
Medical Device Problem Codes	Loss of Osseointegration (2408); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	09/27/2011
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 right hip on or about (b)(6) 2008 and was revised on (b)(6) 2011.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue.
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 right hip on or about (b)(6) 2008 and was revised on (b)(6) 2011.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving an accolade stem was reported.The event was confirmed via medical review.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: "conclusion/assessment: a patient underwent a tha in 2008 and a revision surgery in 2011.The femoral component was found to be loose at the revision.A 40mm cocr head was used in both cases.Event confirmation: a primary tha with an lfit head can be confirmed.A revision surgery for femoral loosening and use of a cocr head can also be confirmed.Injury and device recall cannot be confirmed.Root cause: the root cause of the primary hip was djd.The root cause for the revision was femoral loosening.Again, injury and/or device recall were not confirmed thus a root cause cannot be ascertained.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 stem loosening.Conclusion/assessment: a patient underwent a tha in 2008 and a revision surgery in 2011.The femoral component was found to be loose at the revision.A 40mm cocr head was used in both cases.Event confirmation: a primary tha with an lfit head can be confirmed.A revision surgery for femoral loosening and use of a cocr head can also be confirmed.Injury and device recall cannot be confirmed.Root cause: the root cause of the primary hip was djd.The root cause for the revision was femoral loosening.Again, injury and/or device recall were not confirmed thus a root cause cannot be ascertained.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 (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7911690
• Report Number: 0002249697-2018-03073
• Device Sequence Number: 19194964
• Product Code: LPH
• UDI-Device Identifier: 04546540510778
• UDI-Public: 04546540510778
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024
• 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: 02/28/2011
• Device Catalogue Number: 6021-5537
• Device Lot Number: 16788403
• 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: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2006
• 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: 74 YR
• Patient Sex: Male