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

Catalog Number	6519-T-025
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/29/2019
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.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.Device not returned.
Event or Problem Description
It was reported that total hip prosthesis surgery occurred.Surgeon didn't see any stabilization issue while surgery.After 2 days, surgeon observes a noise from patient hip joint and indicated that it is due to femoral head and taper adapter sleeve.The patient had a revision on april 3rd".
Event or Problem Description
It was reported that total hip prosthesis surgery occurred.Surgeon didn't see any stabilization issue while surgery.After 2 days, surgeon observes a noise from patient hip joint and indicated that it is due to femoral head and taper adapter sleeve.The patient had a revision on (b)(6) 2019".Update: "patient did not suffer any falls or trauma.Revised due to sound from femoral head and adapter sleeve.Left side.No delay.".
Additional Manufacturer Narrative
Additional info: implant and explant dates.An event regarding audible noise involving a other hip sleeve was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned; -medical records received and evaluation: no medical records were received for review with a clinical consultant; -device history review: review of the device history records indicates that all devices were; manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including 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.

• 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: 8594755
• Report Number: 0002249697-2019-01897
• Device Sequence Number: 16660497
• Product Code: JDI
• UDI-Device Identifier: 04546540608383
• UDI-Public: 04546540608383
• Combination Product (Y/N): N
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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: No Information
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 6519-T-025
• Device Lot Number: 68271002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 07/16/2019
• 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