MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6276-1-025
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	10/22/2020
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
It was reported that the patient's left hip was revised due to dissociation of the constrained liner from the shell.Surgeon reported that due to impingement with the stem, the liner was levered out of the shell.Also, the shell was in a neutral position.A shell and 2 screws (implanted in 2011), restoration modular proximal body (implanted in 2013), lfit femoral head and constrained liner (both implanted in 2019) were revised.Rep confirmed that there are no allegations against the revised femoral head, and that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Correction - the restoration modular body was not revised.An event regarding revision involving a restoration modular body was reported.The event was not confirmed.Method & results: - device evaluation and results: not performed as product was not returned.- clinician review: no medical records were received for review with a clinical consultant.- 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: it was reported that the patient's left hip was revised due to dissociation of the constrained liner from the shell.Surgeon reported that due to impingement with the stem, the liner was levered out of the shell.Also, the shell was in a neutral position.The event could not be confirmed nor the exact cause be determined because insufficient information was provided.Additional information including patient details, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that the patient's left hip was revised due to dissociation of the constrained liner from the shell.Surgeon reported that due to impingement with the stem, the liner was levered out of the shell.Also, the shell was in a neutral position.A shell and 2 screws (implanted in 2011), restoration modular proximal body (implanted in 2013), lfit femoral head and constrained liner (both implanted in 2019) were revised.Rep confirmed that there are no allegations against the revised femoral head, and that no further information will be released by the hospital or surgeon.Correction (b)(6) 2021 wg: in reporting a 5th revision on (b)(6) /2021 for this patient's left hip, rep corrected information for the patient's previous revision (this pi).A constrained liner and femoral head were the only devices revised.

• Brand Name: 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025
• 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: 10841562
• Report Number: 0002249697-2020-02459
• Device Sequence Number: 4135399
• Product Code: JDI
• UDI-Device Identifier: 04546540641090
• UDI-Public: 04546540641090
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 10/27/2021

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: 07/31/2018
• Device Model Number: 6276-1-025
• Device Catalogue Number: 6276-1-025
• Device Lot Number: 44407401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 11/15/2020
• Supplement Report FDA Received Date: 10/27/2021
• 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: 56 YR
• Patient Weight: 95