MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PROLONG TIBIAL INSERT SZ 5 +0; PROSTHESIS, ANKLE

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problem Swelling (2091)

Event Date 05/23/2018

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.Concomitant product(s): item # 00450004500, tm ankle tibial base size 5, lot 00077003944; item # 00450002500, talar component green size 5 right, lot # 0062428993n; item # 00493600703, locking one-third tubular plate 7 holes 94 mm length, lot # 00060864063.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 05154, 0001822565 - 2018 - 05155, 0001822565 - 2018 - 05157.

Event Description

It was reported that approximately three (3) years post implantation, the patient noted clicking/locking, with mild swelling and stiffness.X-ray has also indicated subsidence of the talar component.No medical intervention at this time.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were update/corrected updated: reported event was confirmed by review of radiographs.X-ray review demonstrated the subsidence of the talar component.There is also slight increase in density of the talus adjacent to the component.The syndesmotic screw fracture that was previously reported could be a contributing factor to the subsidence.Hcp recommends a ct exam to exclude talar fracture as a cause of subsidence.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined with the information 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: PROLONG TIBIAL INSERT SZ 5 +0
• Type of Device: PROSTHESIS, ANKLE
• 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: 7903347
• MDR Text Key: 121556619
• Report Number: 0001822565-2018-05156
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00450005500
• Device Lot Number: 62560621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/24/2018
• Supplement Dates Manufacturer Received: 10/09/2018
• Supplement Dates FDA Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 122