MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX MODULAR ENDO HEAD 43MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	6942-5-043
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "pt.Presented with a draining surgical wound following a right hemi done "some time ago." explanted items were identified by visible-markings, stem was left in-situ." rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding revision involving a other hip head was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection, functional, dimensional and material analysis of device could not performed as no device was returned medical records evaluation: no medical reports were available for review device history review: not performed as the lot number is unknown.Complaint history review: not performed as the lot number is unknown.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.The following device were also listed in this report: device name#: unitrax v40 sleeve +0mm (std); cat#: 6942-6-065; lot#: unknown.It cannot be determined which, if any of these device may have caused or contributed to the patient's experience.

• Brand Name: UNITRAX MODULAR ENDO HEAD 43MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20452841
• Report Number: 0002249697-2024-01416
• Device Sequence Number: 15625757
• Product Code: KWL
• UDI-Device Identifier: 07613327032376
• UDI-Public: 07613327032376
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K902365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2024

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 Catalogue Number: 6942-5-043
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female