MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNI ADAPTOR SLEEVE V40 TI; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6519-T-100
Medical Device Problem Codes	Material Separation (1562); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/01/2019
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
Universal v40 taper adapter sleeve was shown off of the trunnion in the post op x-ray for a total hip replacement.Update: the head disengaged from the sleeve.Right hip.
Event or Problem Description
Universal v40 taper adapter sleeve was shown off of the trunnion in the post op x-ray for a total hip replacement.Update: the head disengaged from the sleeve.Right hip.
Additional Manufacturer Narrative
An event regarding disassociation involving a sleeve was reported.The event was confirmed by review of the provided medical records by a clinical consultant.Method & results: device evaluation and results: visual inspection: ma: damage consistent with the explantation process was observed on the outer surface of the taper adapter.X-ray fluorescence spectroscopy showed that the adapter base material was consistent with astm f67 (cp ti).Functional and dimensional inspection: due to the damage noted in the visual inspection and the fact that the device was implanted and subsequently explanted, a dimensional or functional inspection of the device in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis: ma: damage consistent with the explantation process was observed on the outer surface of the taper adapter.X-ray fluorescence spectroscopy showed that the adapter base material was consistent with astm f67 (cp ti).Based on the given information, there was no materials or manufacturing discrepancies on the surfaces examined.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: provided undated x-ray image confirms event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Device history review: all 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including primary and revision operative reports, clinical and past medical history and additional serial dated x-rays are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.

• Brand Name: UNI ADAPTOR SLEEVE V40 TI
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9246546
• Report Number: 0002249697-2019-03630
• Device Sequence Number: 17058893
• Product Code: JDI
• UDI-Device Identifier: 04546540608390
• UDI-Public: 04546540608390
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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: 04/30/2024
• Device Catalogue Number: 6519-T-100
• Device Lot Number: 71556903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 01/17/2020
• 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: 75 YR