MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	UH1-44-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report event: an event regarding revision involving a uhr head 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: indicated all devices accepted into final stock from the reported lot were free from discrepancies.   complaint history review: there have been no other similar events for the reported lot.   conclusion: the event could not be determined because insufficient information was provided.Further information such as the reason for revision surgery, return of the device, pre- and post-operative x-rays, primary 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 additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It has been reported by a lawyer - "my client, on (b)(6) 2016, was submitted for surgery of right hip arthroplasty and prosthesis implanted as follows: styker v40tm femoral head - od 28mm - offsr 0mm - ref 6260-5-128 - lot 56124001; abgtm ii femoral stem - right - sze # 3 - sde rt¿ - tpr v40tm - ref 4845-0103 - lot g5531395a; uhr universal head bipolar component - od 44 mm - id 28mm - ref uh1-44-28 - lot t55jyh; my client, right from her application, accused enormous discomfort and mobility problems which, by herself and by the doctors consulted, were linked to the normal period of absorption and adaptation to the aforementioned prosthesis; on (b)(6) 2017, just over a year later, my client was forced to hospitalize again with the following diagnosis: "cotyloiditis in results of hip endoprotesis"; therefore, on (b)(6) 2017, my client underwent a new surgery of "cotile dx replacement"; ".After just over a year to an intervention of replacement of the cup of the arthroplasty implanted in my client.".

• Brand Name: UHR BIPOLAR 28X44MM
• 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: 12123832
• Report Number: 0002249697-2021-01138
• Device Sequence Number: 14656891
• Product Code: JDI
• UDI-Device Identifier: 07613327016895
• UDI-Public: 07613327016895
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

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: 07/31/2021
• Device Model Number: UH1-44-28
• Device Catalogue Number: UH1-44-28
• Device Lot Number: T55JYH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 07/06/2021
• 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