MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 26X56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	UH1-56-26
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2019
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 relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
Primary procedure, right hemi hip.It was reported that once the implant was opened, what appeared to be a hair was observed inside the cavity of the bipolar head itself.Due to sterility concerns, the device was not used and discarded.Another device of the same catalog (different lot) was used to complete the surgery successfully with a delay of approximately 2 minutes.The rep provided a device picture and the implant sheet and reported that no further information will be available.
Additional Manufacturer Narrative
An event regarding foreign matter involving a uhr head was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a recently opened uhr head with the presence of a hair on the device.As the device was opened, it is unknown if the contamination occurred at the manufacturing site or upon opening the device.Material analysis, functional and dimensional inspections were not performed as this event does not relate to these aspects.-clinician review: no medical records were received for review with a clinical consultant.-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 reports and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Primary procedure, right hemi hip.It was reported that once the implant was opened, what appeared to be a hair was observed inside the cavity of the bipolar head itself.Due to sterility concerns, the device was not used and discarded.Another device of the same catalog (different lot) was used to complete the surgery successfully with a delay of approximately 2 minutes.The rep provided a device picture and the implant sheet and reported that no further information will be available.

• Brand Name: UHR BIPOLAR 26X56MM
• 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: 8748879
• Report Number: 0002249697-2019-02438
• Device Sequence Number: 1708750
• Product Code: JDI
• UDI-Device Identifier: 07613327017328
• UDI-Public: 07613327017328
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 10/28/2019

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: 02/29/2020
• Device Catalogue Number: UH1-56-26
• Device Lot Number: YP26RN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 10/28/2019
• 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: Other
• Patient Age: 48 YR