MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 13X145MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Pain (1994); Local Reaction (2035)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 163674 32 mm cocr mod hd 639980, pt-116052 rnglc+ ltd 52mm sz 23 shell 411950, ep-105933 epoly 32mm rlc lnr 151340.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03769.

Event Description

It was reported that patient underwent total hip arthroplasty and was revised over ten years later due to trunnionosis and pain.Sales rep indicates no additional information is available.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ECHO POR FMRL LAT NC 13X145MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10670405
• MDR Text Key: 211329613
• Report Number: 0001825034-2020-03770
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K070274
• 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: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 192113
• Device Lot Number: 207800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2020
• 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: 69 YR