MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 26X43MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	UH1-43-26
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	05/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: 26mm -3 lfit v40 head; 6260-9-026; 61837004, 21mm mod rev hip bdy/blt +10mmcomponent level 9006-1-121; 6276-1-121; 59511803, mod con dist stem 17 x 155 mm; 6276-7-017; caxw60ha, unknown cable; unknown cat#; unknown lot#.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not returned.
Event or Problem Description
It was reported that a stage 1 revision was performed on patient's left hip due to infection.A bipolar component, restoration modular stem system, and cable were removed.An antibiotic spacer was put in.
Additional Manufacturer Narrative
An event regarding infection involving a uhr head was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as the device was not returned.Medical records received and evaluation: the provided medical records and x-rays were rejected for review.Clinician stated "need operative notes, patient clinical notes, histopathology, serial x-rays, and examination of the explanted components." product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there were no other events for the lot and sterile lot provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as operative notes, patient clinical notes, histopathology, serial x-rays, and examination of the explanted components are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that a stage 1 revision was performed on patient's left hip due to infection.A bipolar component, restoration modular stem system, and cable were removed.An antibiotic spacer was put in.

• Brand Name: UHR BIPOLAR 26X43MM
• 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: 7610756
• Report Number: 0002249697-2018-01831
• Device Sequence Number: 1652241
• Product Code: JDI
• UDI-Device Identifier: 07613327016864
• UDI-Public: 07613327016864
• 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: 2018
• 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): 09/07/2018

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: 05/31/2022
• Device Catalogue Number: UH1-43-26
• Device Lot Number: TN0Y67
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 09/07/2018
• 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: 85 YR
• Patient Weight: 77