MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM COCR MOD HD -3MM; PROSTHESIS, HIP

Catalog Number 11-363661

Device Problems Material Erosion (1214); Naturally Worn (2988)

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

Event Date 10/11/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a hip revision approximately 11 years post implantation due to the head wearing into the liner causing metallosis.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown stem, cat #:131150 - mh solid shell ha/pc 50mm ln23 - lot #: 2423032, unknown liner.Foreign source: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02441.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - head: visual examination of the provided pictures identified the liner has damage to the outer articulation surface.No wear can be seen on the inner surface in the provided picture.All components covered in bio-debris; no additional details can be seen on the provided images.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Devices are used for treatment.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination(s).Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is abnormal superolateral subluxation of the femoral head within the cup.Bone quality is osteopenic.There is marked liner wear with malalignment of the femoral head within the cup as noted.Radiolucency is present along the proximal femur consistent with osteolysis.The malalignment/subluxation is secondary to marked liner wear.While metallosis is not seen radiographically, this would contribute to the osteolysis noted.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 original complaint description provided.

• Brand Name: 36MM COCR MOD HD -3MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15698615
• MDR Text Key: 302689372
• Report Number: 0001825034-2022-02442
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K032396
• 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
• Report Date: 11/23/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: 11-363661
• Device Lot Number: 506070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2005
• 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): Hospitalization; Required Intervention
• Patient Sex: Female