MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN LINER; PROSTHETIC, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Concomitant products ¿ unknown head p/n unknown l/n unknown; unknown stem p/n unknown l/n unknown, unknown cup p/n unknown l/n; unknown liner p/n unknown l/n unknown.Multiple mdr reports were filed for this event.Please see reports: 0001825034-2017-05582, 0001825034-2017-05583, 0001825034-2017-05584, 0001825034-2017-05585.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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.Sillesen, nanna h., greene, meridith e., nebergall, audrey k., huddleston, james i., emerson, roger, gebuhr, peter, troelsen, anders, malchau, henrik (2015).Three-year follow-up of a long-term registry-based multicenter study on vitamin e diffused polyethylene in total hip replacement.Hip international, vol 26 issue 1, pages 1-104http://www.Hip-int.Com/article/3-year-follow-up-of-a-long-term-registry-based-multicentre-study-on-vitamin-e-diffused-polyethylene-in-total-hip-replacement.Not returned to manufacturer.

Event Description

It was reported in a journal article that one patient reported perioperative sciatic nerve injury.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: UNKNOWN LINER
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6764609
• MDR Text Key: 81744206
• Report Number: 0001825034-2017-05585
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2017

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: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 08/03/2017
• 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): Other