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

Model Number N/A

Device Problems Corroded (1131); Separation Failure (2547); Naturally Worn (2988)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: canada.Report source: journal: liner dissociation in a large-diameter ceramic-bearing acetabular component: a report of five caseslazaros kostretzis, sagi martinov, martin lavigne, vincent massé, pascal-andré vendittoli: bmc musculoskeletal disorders (2022); 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 review was unable to be performed as the part and lot number of the device involved in the event is unknown.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

It was reported in a journal article that the patient underwent a revision procedure approximately 5 and 1/2 years post implantation due to abrupt pain in the left groin and buttock region.Radiographic evidence displayed millimetric separation of the ceramic insert and pneumarthrosis.During the revision, the ceramic liner was found misaligned.During extraction of the acetabular component, it was impossible to separate the ceramic liner from the titanium shell.Taper modular junction wear and corrosion signs were observed, without metallosis.A 4mm larger than the index, maxera component was implanted.The patient followed standard post-operative rehabilitation without further complications.No further event information available at the time of this report.

• Brand Name: UNKNOWN MAXERA 58MM CUP
• 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: 15606506
• MDR Text Key: 301743483
• Report Number: 0001822565-2022-02965
• Device Sequence Number: 1
• Product Code: KWA
• 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: 10/13/2022

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: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNKNOWN BIOLOX HEAD.; UNKNOWN BIOLOX LINER.; UNKNOWN STEM.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male