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

Model Number N/A

Device Problems Positioning Failure (1158); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 301978237
• Report Number: 0001822565-2022-02591
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024150195
• UDI-Public: (01)00889024150195(11)220406(17)3200403(10)65417695
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K200823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CAT#: 00625006525 BONE SCREW LOT#: 65193843; CAT#: 00771100910 FEMORAL STEM LOT#: 65016722; CAT#: 00877501136 BIOLOX LINER LOT#: 3095836; CAT#: 00877503603 BIOLOX HEAD LOT#: 3041356
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 65 KG