MAUDE Adverse Event Report: ZIMMER, INC. TALAR COMPONENT ORANGE SIZE 4 RIGHT; PROSTHESIS, ANKLE SEMI CONSTRAINED

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Anxiety (2328); Discomfort (2330); Depression (2361); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

(b)(6).This report is number 2 of 4 mdrs filed for the same patient (reference 0001822565-2017-04518 / 0001822565-2017-04520 / 0001822565-2017-04521).Concomitant devices ¿ zimmer talar component orange size 4 right, catalog # 00450002400, lot # 77003947; zimmer prolong tibial insert sz 4 +0, catalog # 00450005400, lot # 62579583; zimmer distal lateral fibular plate right 6 holes 106 mm length, catalog # 00235701706, lot number #unknown; zimmer palacos cement, catalog #: ni, lot #: ni.The complaint device is not expected for return currently, as it remains implanted, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.The investigation is in process.

Event Description

It was reported that patient underwent a right ankle procedure.Subsequently, the patient experienced mild swelling, mild stiffness, mild tenderness, mild weakness, mobility issues, some issues with performing usual daily activities, and moderate pain or discomfort noted at six (6) week post-operative follow-up.At the six (6) month post-operative follow-up, mild swelling, mild stiffness, mild to moderate pain or discomfort, and some range of motion restrictions were noted, however it also noted the ankle was better and the patient was satisfied.At the one (1) year post-operative follow-up, mild swelling, mild stiffness, and some problems with performing usual daily activities, moderate pain or discomfort, and some range of motion restrictions.At the two (2) year post-operative follow-up, mild swelling, mild stiffness, some problems with walking, moderate pain or discomfort, and some range of motion restrictions were noted.Additionally, osteolysis was noted on radiograph findings.The patient continues to report that they are satisfied and that the ankle is improving.No further treatment has been indicated at this time.

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.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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: TALAR COMPONENT ORANGE SIZE 4 RIGHT
• Type of Device: PROSTHESIS, ANKLE SEMI CONSTRAINED
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6678402
• MDR Text Key: 78765977
• Report Number: 0001822565-2017-04519
• 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,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00450002400
• Device Lot Number: 77003947
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2014
• 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): Other
• Patient Weight: 100