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

Model Number	UH1-47-28
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Fitting Problem (2183)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2019
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, right hip.It was reported that after assembly, the 28 -4 biolox head would not articulate freely with the uhr bipolar component.The devices were wasted and a 28 -4 lfit head with a competitor bipolar component was used to complete the surgery successfully with a surgical delay of approximately 10 minutes.A usage sheet showing the wasted implants was supplied, and the devices are available for return, but no further information will be available.
Additional Manufacturer Narrative
An event regarding size/fit issue involving a uhr head was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection of the returned device indicates visible scratches on the surface of the head was observed that consistent with the assembly attempt.Dimensional inspection not performed as device has been assembled.Polyethylene component would have been deformed as a result and in its current condition would not be an accurate reflection of its original manufactured condition.-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: dimensional inspection not performed as device has been assembled.Polyethylene component would have been deformed as a result and in its current condition would not be an accurate reflection of its original manufactured condition.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be re-opened.
Event or Problem Description
Primary procedure, right hip.It was reported that after assembly, the 28 -4 biolox head would not articulate freely with the uhr bipolar component.The devices were wasted and a 28 -4 lfit head with a competitor bipolar component was used to complete the surgery successfully with a surgical delay of approximately 10 minutes.A usage sheet showing the wasted implants was supplied, and the devices are available for return, but no further information will be available.

• 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: 8946999
• Report Number: 0002249697-2019-03040
• Device Sequence Number: 2609155
• Product Code: JDI
• UDI-Device Identifier: 07613327016970
• UDI-Public: 07613327016970
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/02/2020

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: 02/28/2023
• Device Model Number: UH1-47-28
• Device Catalogue Number: UH1-47-28
• Device Lot Number: 3V6XTR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 06/02/2020
• 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
• Patient Age: 62 YR