MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/L TAPER G2 MODULAR NECK; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Naturally Worn (2988)

Patient Problems Bone Fracture(s) (1870); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Local Reaction (2035); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Osteopenia/ Osteoporosis (2651); Limited Mobility Of The Implanted Joint (2671); Metal Related Pathology (4530)

Event Date 12/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: femoral head sterile product do not resterilize 12/14 taper, (pn 00801803202, ln 62832153).M/l taper femoral stem with kinectiv technology, (pn 00771301500, ln62808135).Trilogy acetabular shell, (pn 00620005622, ln 62747453).Trilogy acetabular liner, (pn 00631005632, ln 62757063).Mdr: 0002648920-2019-00737, 0001822565-2019-04393.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.

Event Description

(b)(6) was reported patient underwent left total hip arthroplasty.Subsequently, the patient underwent a revision procedure approximately three years post-implantation due to pain and inability to function.During the procedure, the surgeon noted a bulging mass emanating from the hip socket and large synovial collection of caseating dry debris upon entering the joint.Further, the surgeon noted adverse local tissue reaction (altr) which led to a small calcar fracture; one cable was placed for support.Finally, the surgeon noted the stem was not loose; however, there was only ingrowth along the calcar with minimal along the shoulder.The stem, polyethylene liner, femoral head and taper were removed and replaced.

Manufacturer Narrative

Reported event was confirmed by review of medical records were provided and reviewed by a health care professional.Review of the available records identified the following : the patient underwent a left total hip arthroplasty, during which zimmer biomet products were implanted without complications.The patient underwent a revision procedure on, due to increasing pain and inability to function.Pre-operative mri showed reactive bone changes throughout proximal femur with a large area of synovitis and swelling around the joint indicative of particulate debris process.There was a large synovial collection of caseating dry debris classic for altr secondary to the metal debris or corrosion likely caused by the modular neck/body interface.The capsule was overgrown and redundant.The proximal bone was porosu and friable.The only real bony ingrowth was along the calcar with minimal along the shoulder.The femoral head, liner, neck, and stem were removed.During removal of the stem, a small calcar fracture occurred and was fixed by placing a free single cerclage cable below the lesser trochanter.No other complications or significant findings related to the reported event were identified.Device history record (dhr) was reviewed and no discrepancies 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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Review of complaint history identified additional similar complaints for the head and neck.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Root cause unchanged.This complaint was confirmed based on the provided medical records 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.

Event Description

There is no update to the prior event description provided.

• Brand Name: M/L TAPER G2 MODULAR NECK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9177527
• MDR Text Key: 164266713
• Report Number: 0001822565-2019-04392
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• 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: 00784800200
• Device Lot Number: 62764670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2014
• Is the Device Single Use?: No
• 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): Hospitalization; Required Intervention
• Patient Sex: Male