MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HIP; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Death (1802); Unspecified Infection (1930); Hip Fracture (2349); No Code Available (3191)

Event Type  Death  

Manufacturer Narrative

The product was not returned for evaluation due to unknown location.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) and complaint history review was unable to be performed as the lot/item 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.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Under possible adverse effects: early or late postoperative infection and/or allergic reaction.Postoperative bone fracture and pain.Interoperative or postoperative bone fracture and/or postoperative pain.Following review, no new risks were identified.Literature: virolainen, p., mokka, j., seppanen, m.& makela, k.(2010) up to 10 years follow up of the use of 71 cortical allografts (strut-grafts) for the treatment of periprosthetic fractures.Scandinavian journal of surgery 99: 240¿243, 2010.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.This report is being submitted late as it has been identified in remediation.Zimmer biomet complaint (b)(4).

Event Description

Information was received based on review of a journal article titled, "up to 10 years follow up of the use of 71 cortical allografts (strut-grafts) for the treatment of periprosthetic fractures".It was observed that out of the 20 patients that died, two patients had infected fractures who were previously re-operated with one-stage revision with debridement and reconstruction with a megaprosthesis.The dates of surgeries or specific details have not been provided.There has been no further information provided.

• Brand Name: UNKNOWN HIP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6969961
• MDR Text Key: 89995108
• Report Number: 0001825034-2017-09536
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2016
• 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
• Patient Outcome(s): Death; Hospitalization; Required Intervention