MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-0130
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
Tha implant failure at the neck-head junction.Severe accolade taper corrosion and before the surgery corrosion has caused severe pain.R revised the stem and head and used bigger accolade.
Event or Problem Description
Tha implant failure at the neck-head junction.Severe accolade taper corrosion and before the surgery corrosion has caused severe pain.R revised the stem and head and used bigger accolade.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and wear involving an accolade stem was reported.The event is confirmed based on medical review.Method & results: -product evaluation and results: visual inspection: visual inspection was performed as part of the material evaluation and indicated the following comments: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of a capa.No further material analyses were performed.Dimensional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Functional inspection: not performed as the functional aspects are not in question.Material analysis: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of a capa.No further material analyses were performed -medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: review of the records provided confirmed the implant dissociation and trunnion wear.Review of implant stickers could define if this was a recalled head lot.Obtaining the implant may provide additional insight into the mechanism of dissociation.-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 an nc and capa.The event is confirmed based on medical review.A review of the provided medical records by a clinical consultant indicated: review of the records provided confirmed the implant dissociation and trunnion wear.Review of implant stickers could define if this was a recalled head lot.Obtaining the implant may provide additional insight into the mechanism of dissociation.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.

• Brand Name: ACCOLADE TMZF HIP STEM #1
• 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: 10834912
• Report Number: 0002249697-2020-02441
• Device Sequence Number: 16869778
• Product Code: LPH
• UDI-Device Identifier: 04546540510532
• UDI-Public: 04546540510532
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: 06/30/2013
• Device Model Number: 6020-0130
• Device Catalogue Number: 6020-0130
• Device Lot Number: 26682101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 09/21/2021
• 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 Weight: 83