MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX MODULAR ENDO HEAD 49MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6942-5-049
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a unitrax head 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: a review of the provided x-ray by a clinical consultant indicated: provided pre-revision x-ray does not confirm the reported event.Need primary/revision operative reports, office/clinical reports, serial x-rays, and examination of the 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 operative primary/revision operative reports, office/clinical reports, serial x-rays, and examination of the explanted components are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.The following devices were also listed in this report: unitrax c-taper sleeve -3mm; cat#6942-7-060jr; lot#46721802.Secur-fit arc/ha collar stem#9; cat#s-2337-hf09; lot#mnmt9m.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that the patient's hip was revised due to pain.Patient was converted from a hemi to a total hip.The bipolar component and femoral head were revised, the stem was not.Update 21/january/2019: rep provided primary and revision implant sheets.A unitrax bipolar component and c-taper neck adjustment sleeve were revised to a biolox 36 +7.5 head.The stem was not revised and no stryker acetabular devices are listed on the revision implant sheet.

• Brand Name: UNITRAX MODULAR ENDO HEAD 49MM
• 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: 8336280
• Report Number: 0002249697-2019-01035
• Device Sequence Number: 16519049
• Product Code: JDI
• UDI-Device Identifier: 07613327032437
• UDI-Public: 07613327032437
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

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: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 6942-5-049
• Device Lot Number: A13M163
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/13/2019
• 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
• Patient Age: 68 YR