MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X50MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number	UH1-50-28
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	03/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
This pi is for revision of patient's right hip on (b)(6) 2019.As reported: "recently revised patient ((b)(6) 2019) presented with dissociated and dislocated uhr bipolar construct.Lfit 28mm v40 head remained attached to trunnion of existing accolade c stem, however 50/28 bipolar head was dissociated from inner head and dislocated from acetabulum.Surgeon claimed "inner ring" of uhr head was "cracked" but attempted to re-associate the explanted 28mm lfit head before pictures could be taken.Revision was deemed as necessary due to instability; surgeon deepened the native acetabulum and replanted a 50mm unitrax component with +4mm v40 sleeve.Awaiting return of explanted implants from hospital decontamination".Update (b)(6) 2019: spoke to rep.No possible cause or contributor for disassociation or dislocation was reported to rep (i.E.Trauma, patient factors, etc.).
Additional Manufacturer Narrative
An event regarding disassociation and dislocation involving a uhr bipolar head was reported.The event was confirmed by medical review.Method & results product evaluation and results: the pictures at the event showed a recently explanted bipolar head with the metal head were in an assembled condition.The pictures of the returned device show the bipolar head with the metal head were in an assembled condition.Nothing else remarkable to report.Medical records received and evaluation: a review of the provided medical records was deemed insufficient by a clinical consultant stated the following comment: "provided x-ray confirms disassociation and dislocation.Need operative reports, office/clinical reports, 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 have been no other similar events for the lot referenced.Conclusions: the returned device show the bipolar head with the metal head were in an assembled condition.Nothing else remarkable was noticed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
This pi is for revision of patient's right hip on (b)(6) 2019.As reported: "recently revised patient (b)(6) 19) presented with dissociated and dislocated uhr bipolar construct.Lfit 28mm v40 head remained attached to trunnion of existing accolade c stem, however 50/28 bipolar head was dissociated from inner head and dislocated from acetabulum.Surgeon claimed "inner ring" of uhr head was "cracked" but attempted to re-associate the explanted 28mm lfit head before pictures could be taken.Revision was deemed as necessary due to instability; surgeon deepened the native acetabulum and replanted a 50mm unitrax component with +4mm v40 sleeve.Awaiting return of explanted implants from hospital decontamination." update march 11, 2019: spoke to rep.No possible cause or contributor for disassociation or dislocation was reported to rep (i.E.Trauma, patient factors, etc.).

• Brand Name: UHR BIPOLAR 28X50MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8487661
• Report Number: 0002249697-2019-01556
• Device Sequence Number: 1871430
• Product Code: JDI
• UDI-Device Identifier: 07613327017076
• UDI-Public: 07613327017076
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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 Expiration Date: 08/31/2019
• Device Catalogue Number: UH1-50-28
• Device Lot Number: MNMT9L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Received by Manufacturer: 03/10/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 06/18/2019
• 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: 72 YR