MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM COCR MOD HD +9MM; PROSTHETIC, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Ossification (1428); Pain (1994); Local Reaction (2035); Tissue Damage (2104); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis.Not returned by patient; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-04464.

Event Description

It was reported the patient underwent a hip revision 11 year after implantation due to corrosion at head neck junction.Head and liner were revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Supplied photo was enlarged and on the head you can see 072330, +9mm, b and blood obscures any other information.Also, a damaged liner with no visible information and a locking ring with no visible information can be seen.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.

• Brand Name: 36MM COCR MOD HD +9MM
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11111163
• MDR Text Key: 226110822
• Report Number: 0001825034-2020-04463
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K032396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

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 Expiration Date: 02/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 11-363665
• Device Lot Number: 072330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ITEM#00630505636 NAME LINER STD 3.5 MM LOT#UNK
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 100