MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	UH1-54-28
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2019
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.
Event or Problem Description
Black staining of uhr head.Update august 15th; spoke to rep.This was a primary surgery case further to trauma for a hip fracture where they were implanting exeter stem and uh1 head into the patient.Black staining was noticed and not used.Another was used instead.No impact to patient.There was no revision for this patient.
Event or Problem Description
Black staining of uhr head.Update august 15th; spoke to rep.This was a primary surgery case further to trauma for a hip fracture where they were implanting exeter stem and uh1 head into the patient.Black staining was noticed and not used.Another was used instead.No impact to patient.There was no revision for this patient.
Additional Manufacturer Narrative
An event regarding foreign matter involving uhr head was reported.The event was confirmed through visual inspection method & results: device evaluation and results: visual inspection visual inspection was performed as part of the material evaluation and indicated the following comments: device was returned without the outer foil lidding.Inner lidding has been taped closed with masking tape.Two specs of debris were located on the polymer component of the device.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Material analysis: mar not performed as the reported event relates to a packaging issue.Unable to determine source of debris due to insufficient debris observed at the current time.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: no further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UHR BIPOLAR 28X54MM
• 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: 8959554
• Report Number: 0002249697-2019-03071
• Device Sequence Number: 3146912
• Product Code: JDI
• UDI-Device Identifier: 07613327017250
• UDI-Public: 07613327017250
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: 01/31/2024
• Device Model Number: UH1-54-28
• Device Catalogue Number: UH1-54-28
• Device Lot Number: VX5764
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 02/20/2020
• 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: Other