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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Impaired Healing (2378)

Event Date 12/29/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant devices ¿ unknown head catalog #: ni lot #: ni, unknown shell, catalog #: ni, lot #: ni, unknown liner ,catalog #: ni, lot #: ni. It is indicated by the complainant that the devices will not be returned to zimmer biomet for investigation, as the devices remain implanted. The complaint sample was not evaluated, but the reported event was confirmed through review of medical records. A device history record review was unable to be performed as the lot number of the device involved in the event is unknown. Review of operative notes confirms that the patient underwent local superficial wound debridement and closure. Indication was large nonhealing central necrotic area, which appears to be skin and fat necrosis. It did not appear to be infected. The wound was debrided and irrigated with no additional findings noted. The complaint documents stated results of cbc, esr, and crp levels were within normal limits when the patient returned a few days post-debridement. A 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08052; 0001825034-2018-08053; 0001825034-2018-08054. Device remains implanted.

Event Description

It was reported that the patient underwent superficial wound debridement and closure to treat non-healing in the central necrotic area less than two (2) months following hip arthroplasty. No additional patient consequences were reported.

• Brand Name: UNKNOWN TAPERLOC STEM
• 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: 7772304
• MDR Text Key: 116735882
• Report Number: 0001825034-2018-08051
• Device Sequence Number: 1
• Product Code: KWA
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model 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: 07/12/2018
• 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 Treatment Data

Date Received: 08/10/2018 Patient Sequence Number: 1