MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-0840
Medical Device Problem Codes	Degraded (1153); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	09/25/2019
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's right hip was revised due to disassociation of the head from the stem and trunnion wear after patient experienced "a tremendous amount" of pain after standing from a seated position.The head and stem were revised.The devices are allegedly available for return and the rep provided the primary operative report.Rep confirmed that no further information will be available.
Event or Problem Description
It was reported that the patient's right hip was revised due to disassociation of the head from the stem and trunnion wear after patient experienced "a tremendous amount" of pain after standing from a seated position.The head and stem were revised.The devices are allegedly available for return and the rep provided the primary operative report.Rep confirmed that no further information will be available.
Additional Manufacturer Narrative
An event regarding disassociation and wear involving a accolade stem was reported.Material analysis of the returned devices confirmed the loss of taper lock between the femoral head and stem and stem trunnion wear.Method & results: product evaluation and results: visual inspection of the returned device noted the following: the returned hip stem is exhibited in figures 1-8.Images were obtained for the stem from the anterior, posterior, inferior, and superior view in figures 3-6.Damage was observed on the stem consistent with the implantation/explantation process on the neck and main body figures 4, 5 and 7.Damage was observed on the stem trunnion consistent with the loss of taper lock figure 8.Material analysis of the returned device noted the following: damage consistent with the implantation/explantation process was observed on the stem neck and main body.Damage consistent with loss of taper lock was observed on the stem trunnion.Evidence of impingement from the stem was observed on the distal rim of the head.Discoloration was observed on the articulating surface of the head and the source was unable to be determined.Debris was observed on the taper of the head consistent with the base material, material transfer from the stem, an oxide, and a biological material.Elemental analysis confirmed that the base material of the head is consistent with an astm f1537 and the stem is consistent with an astm f1813 alloy.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-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: material analysis concluded that damage consistent with loss of taper lock was observed on the stem trunnion.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ACCOLADE TMZF HIP STEM #8
• 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: 9221446
• Report Number: 0002249697-2019-03589
• Device Sequence Number: 14133748
• Product Code: LPH
• UDI-Device Identifier: 04546540510600
• UDI-Public: 04546540510600
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2019

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: 07/31/2014
• Device Catalogue Number: 6020-0840
• Device Lot Number: 30526903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 12/27/2019
• 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: 72 YR
• Patient Weight: 91