MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 26X45MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number	UH1-45-26
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: 26mm -3 lfit v40 head; cat # 6260-9-026; lot # 80619806, accolade c cs 132 nk; cat # 6058-0537d; lot # kj1389, accolade distal spacer; cat # 1059-4515; lot # e2591k.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding infection involving a uhr bipolar head was reported.The event was not confirmed method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinical review: no medical records were received for review with a clinical consultant.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot and for sterile lot.Conclusion: the event of infection was not confirmed.The root cause could not be determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as pre- and post-op x- rays, pathology report & follow-up notes are needed to investigate this event further.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.If additional information and/or device becomes available, this investigation will be reopened.Product surveillance will continue to monitor for trends.
Event or Problem Description
As reported: "pt.Presented with symptoms of an infection.Pt.Was brought to the operating room for an ¿irrigation & debridement¿ and swapping of bipolar-head components as per dr¿s i&d protocol(s).The femoral head and uhr/ uht bipolar component that went in on (b)(6) 2021 were replaced.The cemented stem was not changed.No complaints filed against the implants themselves." spoke to rep, who provided the primary and revision usage sheets and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: UHR BIPOLAR 26X45MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11633440
• Report Number: 0002249697-2021-00636
• Device Sequence Number: 19682392
• Product Code: KWL
• UDI-Device Identifier: 07613327016925
• UDI-Public: 07613327016925
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K800207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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: 08/31/2025
• Device Model Number: UH1-45-26
• Device Catalogue Number: UH1-45-26
• Device Lot Number: A76252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/08/2021
• 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: 72 YR