MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM M2A MOD HEAD STD NK; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Sleep Dysfunction (2517)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr¿s were submitted for this event.Please see reports: 0001822565-2017-06586.Concomitant medical products: 103532 ti low profile screw 6.5x25mm, l/n 900440; 15-103684 m2a-t univ 2-hole shl sz 41/54, l/n 074300; 103534 ti low profile screw 6.5x35mm, l/n 230630; 13-103209 taperloc por red/lat 17.5x155, l/n 650940; 15-105004 m2a-taper liner sz 41/32, l/n 809170; 11-163669 32mm m2a mod head std nk, l/n 175650.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a hip revision occurred due to patient preference.The patient reported non-specific symptoms such as not sleeping and felt it was the metal on metal bearing articulation causing the problems.The metal liner and femoral head were removed and replaced with a poly liner and new femoral head.No delay to surgery or additional patient consequences were reported.No further information has been made available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.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.

• Brand Name: 32MM M2A MOD HEAD STD NK
• 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: 6895466
• MDR Text Key: 87451280
• Report Number: 0001825034-2017-07235
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

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 Expiration Date: 11/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 11-163669
• Device Lot Number: 175650
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 10/18/2017
• Supplement Dates FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2004
• 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): Hospitalization; Required Intervention