MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM I.D. SIZE II NEUTRAL LINER USE WITH 52MM O.D. SIZE II SHELL; PROTHESIS, HIP

Model Number N/A

Device Problem Peeled/Delaminated (1454)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 02/10/2023

Event Type  Injury  

Event Description

It was reported the patient had an initial right total hip arthroplasty and was revised thirteen years post implantation due to pain and possible infection.During the revision, it was noted there was no infection, metallosis, or effusion.Delamination and wear to liner and bony impingement to acetabular rim were noted.The liner and head were exchanged without complications.

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801802801 - femoral head - 61382314.Report source: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2023-00041.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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 and/or corrected information.Updated: g3, g6, h2, h3, h6 visual examination of the provided pictures identified wear to the liner on the rim and the inner spherical surface.No damage noted to the head.Both devices have bio-debris on them.No further evaluation can be made from the provided pictures.Device history records were not reviewed as it was determined by a hcp that the reported event was procedure related and not device related.Additionally, part and lot of the liner was not provided.Chs was not performed as it was determined by a hcp that the reported event was procedure related and not device related.Additionally, part and lot of the liner was not provided.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed on (b)(6), 2010.The patient began experiencing pain and a revision was performed on (b)(6) 2023.During the revision, delamination and wear of the liner was identified as well as a bony impingement anteriorly to the acetabular rim.The liner and head were explanted and replaced.No problem was found with the reported device.After review by a hcp it was determined the bony impingement located anteriorly on the acetabular rim is what caused the reported issues.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.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.D10: 00801802801 femoral head sterile product do not resterilize 12/14 taper 61382314.Review of the device history record identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.However, as the shell and stem used are unknown, it's unknown if the entire construct is compatible.Root cause unchanged, no problem found with the device.This complaint was confirmed based on the provided pictures and medical records.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.

Event Description

No additional event information to report at this time.

• Brand Name: 28MM I.D. SIZE II NEUTRAL LINER USE WITH 52MM O.D. SIZE II SHELL
• Type of Device: PROTHESIS, 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: 16513385
• MDR Text Key: 310980422
• Report Number: 0001822565-2023-00612
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151448
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 00875101028
• Device Lot Number: 61287089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2009
• 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; SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 27 YR
• Patient Weight: 67 KG