MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6721-0435
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding disassociation an accolade stem was reported.The event of disassociation was not confirmed.Method & results -product evaluation and results: visual inspection, material analysis, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: the event of disassociation was not confirmed.Further information such as pre- and post-operative x-rays, 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 become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported by the patient's attorney that allegedly on (b)(6), 2012 the patient was implanted with an lfit anatomic femoral head and accolade ii stem in her right hip.It is further alleged that the patient was revised on (b)(6), 2021 with a preop diagnosis of "head neck dissociation".

• Brand Name: SIZE 4 ACCOLADE II 127 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16687893
• Report Number: 0002249697-2023-00362
• Device Sequence Number: 12626261
• Product Code: LPH
• UDI-Device Identifier: 04546540669490
• UDI-Public: 04546540669490
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K103479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2023

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: 10/31/2017
• Device Model Number: 6721-0435
• Device Catalogue Number: 6721-0435
• Device Lot Number: 41548408
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2012
• 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; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female