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 Ecchymosis (1818); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Anxiety (2328); Discomfort (2330); Depression (2361)

Event Date 05/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).This report is number 2 of 3 mdrs filed for the same patient (reference 0001822565 - 2017 - 04416 / 0001822565 - 2017 - 04417 / 0001825034 - 2017 - 04312 ).Concomitant devices zimmer tm ankle tibial base size 4, catalog #: 00450004400, lot # : 77003681, biomet prolong tibial insert sz 4 +0 catalog # : 00450005400, lot # : 62208575.The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.

Event Description

It was reported that patient underwent right ankle surgery.Subsequently, the patient experienced right ankle pain through two and a half year follow-up visits and symptoms as reported at time intervals as follows: six week follow-up (6 weeks): ecchymosis, moderate tenderness, mild swelling, mild stiffness, unable to perform normal activities, moderate pain, ambulation difficulties.At six (6) month follow-up: some problems with mobility, problems performing normal activities, severe pain.At one (1) year follow-up: mild swelling/tenderness, some mobility/ambulation problems, slight problems with performing usual activities, moderate pain.At two (2) year: mild swelling, problems with mobility/ambulation, severe pain, discomfort.The patient was prescribed narcotics and pain management at some point prior to two and a half year follow-up, however, outcome to the pain is still pending.

Manufacturer Narrative

(b)(4).Correction: this report is number 2 of 3 mdrs filed for the same patient (reference 0001822565-2017-04416 / 0001822565-2017-04417 /0001822565-2017-04423).

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.It is noted in primary op-notes that "the trials showed good stability" and "postoperative views were obtained showing good position and alignment of the hardware." furthermore, it was stated that the device has not failed and is still implanted and working as intended.No known contributing conditions related to the ¿continued ankle pain¿.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.

• 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: 6664707
• MDR Text Key: 78312362
• Report Number: 0001822565-2017-04417
• 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: 10/20/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00450002400
• Device Lot Number: 62397421N
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: Not provided; 10/06/2017
• Supplement Dates FDA Received: 06/23/2017; 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2013
• 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 Age: 59 YR
• Patient Weight: 64