MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	UH1-46-28
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
It is reported that a stryker head was not sliding smoothly in the uhr bipolar cup.
Additional Manufacturer Narrative
An event regarding disassociation involving a uhr bipolar component was reported.Conclusion: it was reported that the head was not sliding smoothly in the uhr bipolar cup.Visual inspection of the returned device noted that device was returned in used condition.The head was found attached with the bipolar component.The label on the head was of different manufacturer "microport".No major damages were observed on the device.Based on the provided information it has been determined that this event is associated with an off-label application.The ifu label packaged with the device indicates that, "howmedica osteonics corp.Strongly advises against the use of another manufacturer¿s femoral stem component with any howmedica osteonics¿ bipolar component.Any such use will negate the responsibility of howmedica osteonics corp.For the performance of the resulting mixed component implant." no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It is reported that a stryker head was not sliding smoothly in the uhr bipolar cup.

• Brand Name: UHR BIPOLAR 28X46MM
• 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: 7493722
• Report Number: 0002249697-2018-01358
• Device Sequence Number: 1417315
• Product Code: JDI
• UDI-Device Identifier: 07613327016956
• UDI-Public: 07613327016956
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: UH1-46-28
• Device Lot Number: 3P0D3T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 07/26/2018
• 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: Other