MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 26X46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	UH1-46-26
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Injury (2348); Joint Dislocation (2374)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported relevant 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
It was reported that patient's right hip was revised due to a dislocation after patient suffered a fall.An lfit cocr head and uhr bipolar component were revised to a higher-diameter stryker lfit head with competitor shell and liner.A review by a clinical consultant indicated: xrays reviewed demonstrate the patient suffered a periprosthetic posterior acetabular wall fracture with subluxation of the bipolar component.
Event or Problem Description
It was reported that patient's right hip was revised due to a dislocation after patient suffered a fall.An lfit cocr head and uhr bipolar component were revised to a higher-diameter stryker lfit head with competitor shell and liner.A review by a clinical consultant indicated: xrays reviewed demonstrate the patient suffered a periprosthetic posterior acetabular wall fracture with subluxation of the bipolar component.
Additional Manufacturer Narrative
An event regarding dislocation involving a uhr head was reported.Upon review of the provided medical records an periprosthetic fracture of the acetabulum was confirmed.Dislocation was not confirmed.Method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-medical records received and evaluation: a review of the provided medical records by a clinical consultant noted; conclusion of assessment the report of a dislocation i.E., dissociation of a tha stem and femoral head, is not confirmed.However, it is confirmed that a periprosthetic acetabular fracture with subluxation of the bipolar hemiarthroplasty due to a fall did occur.No documentation regarding subsequent treatment revision to a higher diameter stryker lfit head with a competitor shell and liner was provided.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusion: the reported event of dislocation was not confirmed.A review of the provided medical records by a clinical consultant concluded the report of a dislocation i.E., dissociation of a tha stem and femoral head, is not confirmed.However, it is confirmed that a periprosthetic acetabular fracture with subluxation of the bipolar hemiarthroplasty due to a fall did occur.No documentation regarding subsequent treatment revision to a higher diameter stryker lfit head with a competitor shell and liner was provided.Further information such as return of device, operative reports, surgical implant records from the surgeries, dated pre and post op x-rays from the index and revision surgeries & outpatient office/clinic notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.

• Brand Name: UHR BIPOLAR 26X46MM
• 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: 7635596
• Report Number: 0002249697-2018-01955
• Device Sequence Number: 2281565
• Product Code: JDI
• UDI-Device Identifier: 07613327016949
• UDI-Public: 07613327016949
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

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: 08/31/2022
• Device Catalogue Number: UH1-46-26
• Device Lot Number: 8R7RAH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 08/20/2018
• 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: 75 YR
• Patient Weight: 73