MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 54MM O.D. SIZE JJ POROUS UNCEMENTED WITH CLUSTER HOLES SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Positioning Failure (1158); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the implantation of the acetabular cup, the cup did not feel tight when tapped.During investigation, it was determined to have loosened.No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: implant disassembly with surrounding liner becoming dislodged and abnormally positioned medial to the femoral head component.No obvious signs of loosening, wear, radiolucency, or other contributing factors were identified.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2022-00190.

• Brand Name: 54MM O.D. SIZE JJ POROUS UNCEMENTED WITH CLUSTER HOLES SHELL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15628796
• Report Number: 0001822565-2022-02591
• Device Sequence Number: 7169362
• Product Code: JDI
• UDI-Device Identifier: 00889024150195
• UDI-Public: (01)00889024150195(11)220406(17)3200403(10)65417695
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2022

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: 00875305401
• Device Lot Number: 65417695
• 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: 10/10/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CAT#: 00625006525 BONE SCREW LOT#: 65193843; CAT#: 00771100910 FEMORAL STEM LOT#: 65016722; CAT#: 00877501136 BIOLOX LINER LOT#: 3095836; CAT#: 00877503603 BIOLOX HEAD LOT#: 3041356
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 65 KG