MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 52 MM O.D.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant products: 00500105028 ¿ pe bipolar liner ¿ 64774232; 802202803 ¿ cocr head ¿ 64877525; unknown stem - unknown part and lot.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product was discarded.The investigation is in process.Once the investigation has been completed a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2021 - 00111.
Event or Problem Description
It was reported that patient presented to the hospital emergency department due to right hemi arthroplasty dislocation approximately 20 days after implantation.During closed reduction, the outer ball and plastic disassociated.The patient was admitted for a revision surgery.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: primary op notes were reviewed and no complications were noted.Medical notes were reviewed and the following were identified: 75yo male fell asleep on couch with 'his leg over the back' and not sure when it dislocated.Right periprosthetic hip dislocation with failure of closed reduction in ed, which resulted in dissociation of the bipolar head.Right hip open reduction with replacement of bipolar head.Upon opening, found 'outer ball and plastic was dissociated', large hematoma, which would not be considered abnormal post dislocation and attempts of closed reduction.Some tissue damage was noted and 'friable' areas were debrided and irrigated.The bipolar head was removed, cultures taken, and new head placed.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: SHELL 52 MM O.D.
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11782309
• Report Number: 0002648920-2021-00110
• Device Sequence Number: 19741602
• Product Code: KWY
• UDI-Device Identifier: 00889024115484
• UDI-Public: (01)00889024115484(17)300228(10)64707287
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K833991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00500105200
• Device Lot Number: 64707287
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention