MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER AND SHELL WITH PLASTIC BARRIER 44 MM I.D. 54 MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 01/24/2023

Event Type  Injury  

Event Description

It was reported that while vacuuming, the patient felt a cracking and dislocation sensation.The x-ray and the surgical procedure showed a decoaptation/disassociation between the ceramic liner and the metal back of the implanted maxera cup.A complete intervention was performed, and the cup was replaced by a new one.There were no contributing patient conditions related to the event.No additional information.

Manufacturer Narrative

(b)(4).Report source: country: belgium.Implanted date: (b)(6) 2015.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4,d4,d9,g3,h2,h4 product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further event information is available at the time of this report.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6.The product was returned and evaluated.A visual examination of the returned product identified that the ceramic shell and metal liner were returned disassociated.The ceramic shell showed wear from use.Nicks, scratches, discoloration, and color worn away were noted.The metal shell showed deformation and gouge damage on the rim.The outer spherical surface had embedded bio debris.The inner spherical surface showed discoloration and foreign debris.No other damage was noted.The issue was confirmed based on the returned device.Medical records were not provided; however, radiographs were provided and reviewed by a health care professional.A review of the available records identified the following: disassociation of the right hip arthroplasty implants as noted.The reported maxera cup and ceramic head were reviewed for compatibility with no issues noted.However, as the taper adapter and stem used are unknown, it is unknown if the entire construct is compatible.A review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.

• Brand Name: LINER AND SHELL WITH PLASTIC BARRIER 44 MM I.D. 54 MM
• 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: 16310941
• MDR Text Key: 308921340
• Report Number: 0001822565-2023-00257
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NI
• 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,Followup
• Report Date: 04/19/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00151505444
• Device Lot Number: 62681035
• 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: 01/24/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 03/16/2023; 04/18/2023
• Supplement Dates FDA Received: 03/27/2023; 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2014
• 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
• Patient Outcome(s): Required Intervention; Hospitalization