MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-0537
Medical Device Problem Codes	Corroded (1131); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	01/02/2020
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.
Event or Problem Description
Recalled v40 metal head involved patient pain.
Additional Manufacturer Narrative
Reported event an event regarding a revision surgery due to pain for an accolade stem was reported.Revision was confirmed as the devices were explanted and subsequently, corrosion was confirmed by mar.Method & results -product evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report mar, dated 24-mar-2020.This inspection indicated damage consistent with explantation process was observed on the neck and trunnion of the stem.Damage consistent with head taper and stem trunnion interaction was observed.Biological material was observed on the porous coating of the stem.Debris was observed on the inferior portion of the stem, the debris was analyzed further using a scanning electron microscope sem.Dimensional inspection: dimensional inspection was not performed because the device was returned damaged functional inspection: functional inspection was not performed because the device was returned damaged material analysis: material evaluation was completed and indicated the following comments: damage on the returned head was consistent with interaction against the stem trunnion.Damage consistent with the explantation process was observed on the stem.Eds showed that the stem and head were consistent with their respective drawings.The debris on the each of the components were consistent with an oxide, a corrosion product, biological material, and the stem base alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: no clinical or past medical history, no imaging studies, no examination of the explanted components, and no documented follow-up between the january 7, 2010 index surgery and august 9, 2019 are available.Examination of the explanted components and review of the mri and x-rays, as well as review of histopathology slides would be required to confirm the relationship between the recalled modular head and the symptoms described in this case leading to revision surgery.-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 evaluation was completed and indicated the following comments: damage on the returned head was consistent with interaction against the stem trunnion.Damage consistent with the explantation process was observed on the stem.Eds showed that the stem and head were consistent with their respective drawings.The debris on the each of the components were consistent with an oxide, a corrosion product, biological material, and the stem base alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.
Event or Problem Description
Recalled v40 metal head involved patient pain.

• Brand Name: ACCOLADE TMZF HIP STEM #5
• 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: 9676767
• Report Number: 0002249697-2020-00236
• Device Sequence Number: 2882318
• Product Code: LPH
• UDI-Device Identifier: 04546540510570
• UDI-Public: 04546540510570
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: 11/30/2013
• Device Model Number: 6020-0537
• Device Catalogue Number: 6020-0537
• Device Lot Number: 28065504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 06/07/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 06/16/2020
• 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: 77 YR
• Patient Weight: 100