MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X45MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	UH1-45-28
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	11/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: c-taper cocr lfit head 28mm/0; cat# 06-2800; lot# y92mk6.Omnifit hfx hip stem size #08 132; cat# 6070-0830a; lot# 245plv.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An even regarding infection involving a uhr head was reported.The event was not confirmed.Method & results: device evaluation and results:no product was returned for evaluation however photographs were provided for evaluation.The photograph shows a recently explanted uhr head.Blood is visible on the head.The head appears unremarkable.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, pathology reports, additional serial dated x-rays and examination of explanted components.Device history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusion: the event of infection cannot be confirmed as insufficient information was provided.Further information such as device lot identification, primary and revision operative reports, clinical and past medical history, pathology reports, additional serial dated x-rays and examination of explanted components are required to complete the investigation and determine a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Device not returned.
Event or Problem Description
As reported: "patient had hip joint space infection.Omnifit hfx [with cocr femoral head] and bipolar components explanted.No complications.No visual complications or damage with explants.No previous reports available." rep provided x-rays and explant pictures.

• Brand Name: UHR BIPOLAR 28X45MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9433484
• Report Number: 0002249697-2019-03971
• Device Sequence Number: 14098205
• Product Code: KWL
• UDI-Device Identifier: 07613327016918
• UDI-Public: 07613327016918
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K800207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2019

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 Catalogue Number: UH1-45-28
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2019
• Initial Report FDA Received Date: 12/06/2019
• 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: 70 YR
• Patient Weight: 59