MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-T UNIV 2-HOLE SHL SZ 41/58 PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Unspecified Infection (1930); Pain (1994); Reaction (2414)

Event Date 08/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: 11-163669, 32mm m2a mod head std nk, 523970, 13-103209, taperloc por red/lat 17. 5x155, 085710, 15-103688, m2a-t univ 2-hole shl sz 41/58, 780070, 13-103209, taperloc por red/lat 17. 5x155, 085710, 103537, ti low profile screw 6. 5x50mm, 980780. Reported event was confirmed by review of the provided op notes. Revision op notes indicate patient having drainage through his hip surgical incision site. Patient having hip problems and increased pain before revision. It was evaluated and found out to be mrsa. It was noted that patient's cobalt level was elevated but the chromim was not. Surgeon noted black material along the trunnion consistent with metal corrosion. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required. 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.

Event Description

It was reported that a patient was revised due to infection greater than one year post-operatively, elevated cobalt ion levels, and metallosis. Fluid aspiration was performed prior to the procedure. It was noted that there was yellow fluid with some cloudy consistency. There was also black material in the trunnion that was consistent with metal corrosion. All products were removed and replaced with cement spacer. Attempts have been made and no further information is available at this time.

• Brand Name: M2A-T UNIV 2-HOLE SHL SZ 41/58
• 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: 7476124
• MDR Text Key: 106994517
• Report Number: 0001825034-2018-03120
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 15-103688
• Device Lot Number: 780070
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2005
• 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 Treatment Data

Date Received: 05/01/2018 Patient Sequence Number: 1