MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X47MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	UH1-47-28
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Device not returned to the manufacturer.
Event or Problem Description
Uhr head contaminated with blue and black stuff.During surgery, 2-3 min delay to get a new one from shelf.
Event or Problem Description
Uhr head contaminated with blue and black stuff.During surgery 2-3 min delay to get a new one from shelf.
Additional Manufacturer Narrative
Correction: implant date.An event regarding foreign matter involving a uhr head was reported.The event was confirmed.Method & results: device evaluation and results: the device was returned along with the outer blister tray and implant sticker.The device looked intact but foreign debris are found around the rim of the bearing insert.An ftir analysis was performed on the debris found on the device.The debris was scraped off with a layer of the polyethylene attached to it and analyzed using the atr."the results gave an approximately 85% match for foam or tyvek packaging.Due to the very limited amount of foreign debris available for testing and the nature of the spectrum, it cannot be conclusively stated that the debris was from a foam or tyvek material, but it remains a possibility." see attached report.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event for the foreign matter was confirmed based on the returned device.An ftir analysis was performed on the debris found on the device.The debris was scraped off with a layer of the polyethylene attached to it and analyzed using the atr."the results gave an approximately 85% match for foam or tyvek packaging.Due to the very limited amount of foreign debris available for testing and the nature of the spectrum, it cannot be conclusively stated that the debris was from a foam or tyvek material, but it remains a possibility."based on the results of the analysis, a root cause could not be determined to complete the assessment.It was also indicated in the follow up requests of information that the sales rep was not present during this event to confirm the alleged complaint.No further investigation is needed at this time.

• Brand Name: UHR BIPOLAR 28X47MM
• 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: 8649359
• Report Number: 0002249697-2019-02112
• Device Sequence Number: 254860
• Product Code: JDI
• UDI-Device Identifier: 07613327016970
• UDI-Public: 07613327016970
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 10/31/2023
• Device Catalogue Number: UH1-47-28
• Device Lot Number: L15WEW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 08/20/2019
• 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: 76 YR
• Patient Weight: 76