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	Material Erosion (1214); Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional information become available, it will be provided in a supplemental report upon completion of the investigation 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.Catalog numbers and lot codes of other devices listed in this report: 36mm +5 v40 metal head, lot, unknown; 36mm f 10 deg.Insert, lot, unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient had hip replacement inserted in 2006.Was doing fine until 2 weeks ago and consulted with the dr.Who did revision hip surgery yesterday.
Additional Manufacturer Narrative
Reported event an event regarding disassociation and wear involving an accolade stem was reported.The event was confirmed.Method & results -product evaluation and results: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.No further material analysis is required.-clinician review: a review of the provided medical records by a clinical consultant indicated: confirmation: the event a revision surgery was confirmed via the op note.The revision was for head-stem disengagement.Trunnion wear and metallosis noted at revision.Root cause: the root cause of the dissociation and metallosis was likely an lfit head-trunnion problem.The lot numbers would need to be checked to confirm.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient's hip was revised due to head-stem disengagement.Trunnion wear and metallosis noted at revision.Evaluation on the returned device confirmed that damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.A review of the provided medical records by a clinical consultant confirmed that the revision was performed for head-stem disengagement.Trunnion wear and metallosis noted at revision.The exact cause of the event could not be determined.If further information becomes available or the product is returned, this investigation will be re-opened.Catalog numbers and lot codes of other devices listed in this report: 623-10-36f trident 10° x3 insert 36mm id lot unknown it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient had hip replacement inserted in 2006.Was doing fine until 2 weeks ago and consulted with the dr.Who did revision hip surgery yesterday update per per form: " patient said he felt acute change on his hip per description from op-notes." *update on (b)(6) 2021 per clinician review: "[.] the event a revision surgery was confirmed via the op note.The revision was for head-stem disengagement.Trunnion wear and metallosis noted at revision.[.].

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 11847864
• Report Number: 0002249697-2021-00881
• Device Sequence Number: 3724213
• Product Code: LPH
• UDI-Device Identifier: 04546540510570
• UDI-Public: 04546540510570
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

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: 07/31/2010
• Device Model Number: 6020-0537
• Device Catalogue Number: 6020-0537
• Device Lot Number: 13977703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2005
• 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: 73 YR
• Patient Sex: Male