MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-T M/H RAD 2HL SHL 41/54MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Tingling (2171); Numbness (2415)

Event Date 12/12/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.A concomitant medical products: item # unk, stem, lot # unk, item # 650-1057, head, lot # unk, item # unk, liner, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 06799, 0001825034 - 2018 - 06800, 0001825034 - 2018 - 06802.

Event Description

It was reported that approximately 1 year post implantation, the patient underwent a neurectomy (open) of the lateral cutaneous femoral nerve due to meralgia paresthetica.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

Upon reassessment of the complaint it was determined that the complaint was already reported on 0001825034-2017-11015.The initial report submitted should be voided.

• Brand Name: M2A-T M/H RAD 2HL SHL 41/54MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7765177
• MDR Text Key: 116530934
• Report Number: 0001825034-2018-06797
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10-104054
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 73