MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 7 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6720-0737
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device noted as returned.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
Bipolar cup dislocated from inner head.He had two reduction within two weeks.Update (b)(6) 2022: stem was revised for an unknown reason.
Event or Problem Description
Bipolar cup dislocated from inner head.He had two reduction within two weeks.Update 05-april-2022: stem was revised for an unknown reason.
Additional Manufacturer Narrative
An event regarding revision involving an accolade stem was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that there is some white material adhered to the ha coated portion of the stem, consistent with osseointegration.The device appears undamaged.There is nothing further to note.-clinician review: no medical records were received for review with a clinical consultant.-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 disassociation of the metal head from the bipolar (uhr) head.The stem was also revised for an unknown reason.The exact cause of the event could not be determined because insufficient information was provided.Further information such as 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SIZE 7 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: 14237571
• Report Number: 0002249697-2022-00628
• Device Sequence Number: 4398829
• Product Code: LPH
• UDI-Device Identifier: 04546540664501
• UDI-Public: 04546540664501
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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: 07/31/2026
• Device Model Number: 6720-0737
• Device Catalogue Number: 6720-0737
• Device Lot Number: 85885301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2021
• 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: Male
• Patient Weight: 49 KG