MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK MAXERA 58MM ACETABULUM; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Detachment of Device or Device Component (2907); Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source canada.Doi: https://doi.Org/10.1186/s12891-022-05082-6.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported in a journal article approximately 44 months post left total hip arthroplasty the patient experienced a loud noise on the left side and felt a shock and acute pain in the left limb.Radiographic evidence displayed pneumarthrosis laterally to the acetabulum, which reabsorbed over a two month span.Two months after the incident, the patient underwent a revision and found the ceramic liner slightly displaced in the metal cup but remained stable.Taper modular junction wear and corrosion signs were observed.The maxera cup was removed and replaced with a 2mm larger cup.No additional information.

• Brand Name: UNK MAXERA 58MM ACETABULUM
• 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: 15614722
• MDR Text Key: 301825826
• Report Number: 0001822565-2022-02975
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: No
• 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: UNK BIOLOX DELTA FEMORAL HEAD 48MM; UNK BIOLOX DELTA TAPER LINER; UNK TITANIUM SHELL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male