MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 26MM +4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	UH1-43-26
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); No Information (3190)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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.
Event or Problem Description
As reported: "patient had hip fracture surgery on (b)(6) 2020.On (b)(6) 2020, the doctor informed me that the head was dislocated from the trunnion of the stem.The doctor performed hip revision, removed the initial head from the patient, and implanted another head and bipolar head." spoke to rep: the head and bipolar component were revised but there are no allegations against the revised bipolar component.Rep confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
As reported: "patient had hip fracture surgery on (b)(6) 2020.On (b)(6) 2020, the doctor informed me that the head was dislocated from the trunnion of the stem.The doctor performed hip revision, removed the initial head from the patient, and implanted another head and bipolar head." spoke to rep: the head and bipolar component were revised but there are no allegations against the revised bipolar component.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Additional manufacturer narrative: reported event.An event regarding disassociation involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device indicates that explantation damage was observed.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Material analysis is not performed as disassociation is not related to material integrity issue.Medical records received and evaluation: no medical records were received for review with a clinical consultant.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: visual inspection of the returned device indicates that explantation damage was observed.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Material analysis is not performed as disassociation is not related to material integrity issue.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: 26MM +4 V40 TAPER VIT HEAD
• 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: 10987628
• Report Number: 0002249697-2020-02632
• Device Sequence Number: 14435127
• Product Code: JDI
• UDI-Device Identifier: 07613327016864
• UDI-Public: 07613327016864
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 01/19/2025
• Device Model Number: UH1-43-26
• Device Catalogue Number: 6260-5-226
• Device Lot Number: 77226602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/26/2021
• 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 Age: 84 YR