MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM DIA COCR MOD HD -3MM NK; PROTHESIS, HIPS

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 07/10/2023

Event Type  Injury  

Event Description

It was reported the patient underwent a bilateral hip arthroplasty, patient suffered a dislocation and was revised one month post implantation.The head and liner disassembled when the surgeon was performing repositioning post dislocation.

Manufacturer Narrative

(b)(4).D10: 30302844 ringloc bipolar vit e 28x44mm 65541571.G2: foreign: japan.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01852.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

Proposed component code: mechanical (g04)- head.Visual examination of the returned product identified there was no visible damage to the returned head.The liner had been installed into the shell so no further analysis could be performed.The head height and diameter were checked per the print and found in conformance.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.This complaint was confirmed based on the returned devices.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.

• Brand Name: 28MM DIA COCR MOD HD -3MM NK
• Type of Device: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17493778
• MDR Text Key: 320751881
• Report Number: 0001825034-2023-01854
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 00887868308260
• UDI-Public: (01)00887868308260(17)321206(10)J7399125
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K942479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 163661
• Device Lot Number: J7399125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2022
• 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: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization