MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 6 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6720-0635
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
In email chains provided reporting a damaged instrument, there are statements that the device was being used in the revision of an accolade 2 "permanent" stem.The statement says that the stem could not be removed with the reported device.No apparent information at this time for the reason for revision or how the revision was carried out.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving an accolade stem was reported.The event was not confirmed.Method & results:  -device evaluation and results: not performed as product was not returned.  -clinician review: no medical records were received for review with a clinical consultant.-device history review: all 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: the event itself, or the exact cause of the event could not be confirmed as insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
In email chains provided reporting a damaged instrument, there are statements that the device was being used in the revision of an accolade 2 "permanent" stem.The statement says that the stem could not be removed with the reported device.No apparent information at this time for the reason for revision or how the revision was carried out."multi-recurrent dislocation the reason of the revision is a change of the femoral stem.".

• Brand Name: SIZE 6 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
• MDR Report Key: 10401524
• Report Number: 0002249697-2020-01660
• Device Sequence Number: 19798312
• Product Code: LPH
• UDI-Device Identifier: 04546540664495
• UDI-Public: 04546540664495
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020

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: 01/31/2025
• Device Model Number: 6720-0635
• Device Catalogue Number: 6720-0635
• Device Lot Number: 75967702
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR