MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERIARTICULAR LKNG PLT FIB ST; PLATE, FIXATION

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problem Swelling (2091)

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).Concomitant medical products: 47482801602, 2.7mm univ locking scrs st, 63185762; 47482801602, 2.7mm univ locking scrs st, 63185762; 47482801602, 2.7mm univ locking scrs st, 63185762; 47235901438, periarticular locking scrs st, 63138409; 47482801802, 2.7mm univ locking screws ster, 63115789; 47482801402, 2.7mm univ locking screws ster, 63138387; 47484003501, zps screws sterile, 63337311.Report source, foreign - the event occurred in the (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-02750, 0001822565-2018-02751, 0001822565-2018-02752, 0001822565-2018-02753, 0001822565-2018-02754, 0001822565-2018-02755, 0001822565-2018-02756.

Event Description

It was reported that the patient underwent a right ankle orif (open reduction and internal fixation) due to an ankle fracture.Subsequently, the patient was revised due to redness and swelling, and the explanted products showed signs of corrosion.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was unable to be reviewed as the lot number is unavailable.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

No additional information was received.

Event Description

It was reported that the patient underwent a right ankle orif due to an ankle fracture.Subsequently, the patient was revised due to redness and swelling.The explanted products showed signs of corrosion and metallosis was found intraoperative.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The additional information received would not change the previously reported investigation results.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: PERIARTICULAR LKNG PLT FIB ST
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7533126
• MDR Text Key: 108890842
• Report Number: 0001822565-2018-02749
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: PK070906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 47235701708
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR