MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM COCR MOD HD STD; PROSTEHSIS, HIP

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Tissue Damage (2104)

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant medical products: catalog number:010000936 lot number:3400994 brand name:g7 hi-wall e1 liner.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.Device not returned for evaluation.

Event Description

It was reported that the patient was revised due to due to pain, loosening and possible infection approximately 5 years post implantation.During the surgery the surgeon noted brown tissue which was sent for analysis resulting positive.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.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

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

• Brand Name: 36MM COCR MOD HD STD
• Type of Device: PROSTEHSIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9311172
• MDR Text Key: 170421503
• Report Number: 0001825034-2019-05011
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• 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: 11-363662
• Device Lot Number: 474010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR