MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 53 MM O.D.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a hip revision approximately 1 month post implantation after experiencing recurring dislocations and is non-compliant.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00500105328, liner, 64889621.00811400330, stem, 65139953.802202802, head, unknown lot.Report source australia.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: no acute abnormality of the right hip arthroplasty.A review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined, however, please note that the surgeon stated the patient is non-compliant which put her at an increased risk of having dislocations.However, it's unknown how the patient was being non-compliant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SHELL 53 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
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15549207
• Report Number: 0002648920-2022-00211
• Device Sequence Number: 1806441
• Product Code: KWY
• UDI-Device Identifier: 00889024115491
• UDI-Public: (01)00889024115491(17)311220(10)65345585
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K833991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2022

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: 00500105300
• Device Lot Number: 65345585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 65 KG