MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-0230
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Ambulation or Postural Difficulties (2544)
Date of Event	08/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding disassociation, altr and fretting involving a accolade stem which was mated with a lfit v40 cocr head was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, 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.Conclusions: the reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.The event was not confirmed and the root cause could not be identified.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.Not available.
Event or Problem Description
It was reported by the patient's attorney as a result of a legal claim that allegedly the patient was implanted with an lfit v40 femoral head on (b)(6) 2008 and subsequently developed severe pain in the right hip and the inability to walk or bear weight on the right leg, a large pseudotumor, disassociation between the femoral head and neck and metallosis.It is further alleged the patient underwent revision surgery on (b)(6) 2020.

• Brand Name: ACCOLADE TMZF HIP STEM #2
• 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: 11674827
• Report Number: 0002249697-2021-00686
• Device Sequence Number: 19623025
• Product Code: LPH
• UDI-Device Identifier: 04546540510549
• UDI-Public: 04546540510549
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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: 03/31/2012
• Device Model Number: 6020-0230
• Device Catalogue Number: 6020-0230
• Device Lot Number: 21987002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/15/2021
• 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: 65 YR