MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 26X46MM; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.

Catalog Number	UH1-46-26
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The outer head (46/26) of a bipolar hemi hip disengaged from the inner head (26/+0).The surgeon is confident that she did not impact the outer head onto the inner head with enough force during the first surgery due to patient's poor bone quality.Surgeon does not believe it is a product issue, however a per is still required.
Additional Manufacturer Narrative
An event regarding user error involving an damage uhr bipolar was reported.The event was not confirmed.Method & results: device evaluation and results: the returned device images show damages on the surface.Examination of the returned device with material analysis engineer noted explantation damage.Medical records received and evaluation: the provided medical information was submitted to a consulting clinician who deemed it insufficient for a medical review.Rejected as no op report, no x-rays, no clinical or past history, no patient demographics, only one x-ray and photo image of disengaged bipolar.Need primary & revision op reports and patient demographics.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 event could not be confirmed nor the root cause determined on the basis of material analysis report.Examination of the returned device with material analysis engineer noted explantation damage.The provided medical information was submitted to a consulting clinician who deemed it insufficient for a medical review.Rejected as no op report, no x-rays, no clinical or past history, no patient demographics, only one x-ray and photo image of disengaged bipolar.Need primary & revision op reports and patient demographics.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
The outer head (46/26) of a bipolar hemi hip disengaged from the inner head (26/+0).The surgeon is confident that she did not impact the outer head onto the inner head with enough force during the first surgery due to patient's poor bone quality.Surgeon does not believe it is a product issue, however a per is still required.

• Brand Name: UHR BIPOLAR 26X46MM
• Common Device Name: HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6436033
• Report Number: 0002249697-2017-01019
• Device Sequence Number: 18974036
• Product Code: KWL
• UDI-Device Identifier: 07613327016949
• UDI-Public: (01)07613327016949(11)160502(17)210531(10)WT8M9A
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K800207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: UH1-46-26
• Device Lot Number: WT8M9A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2017
• Supplement Report FDA Received Date: 05/24/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 85 YR