MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 26X55MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number	UH1-55-26
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: 26 mm std v40 taper vit head; cat# 6260-5-126; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An even regarding revision for unspecified reasons involving a uhr head was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no product was returned for evaluation.Clinician review: no medical records were received for review with a clinical consultant device history review: not performed as the lot information provided was invalid.Complaint history review: not performed as the lot information provided was invalid.Conclusion: the event cannot be confirmed as insufficient information was provided.Further information such as the reason for the revision surgery, product details, return of the device, pre- and post-operative x-rays.Operative reports 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.Device not returned.
Event or Problem Description
A revision usage sheet was provided with notes that a patient's left hemi hip was revised to a total hip.A bipolar component and femoral head were removed, and a shell with 3 screws, mdm/adm liner construct, and v40 femoral head were implanted.

• Brand Name: UHR BIPOLAR 26X55MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9641988
• Report Number: 0002249697-2020-00168
• Device Sequence Number: 16654256
• Product Code: KWL
• UDI-Device Identifier: 07613327017298
• UDI-Public: 07613327017298
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K800207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2020

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 Model Number: UH1-55-26
• Device Catalogue Number: UH1-55-26
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/29/2020
• 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: 79 YR
• Patient Weight: 75