MAUDE Adverse Event Report: ZIMMER, INC. TALAR COMPONENT BLUE SIZE 3 LEFT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Swelling (2091); Anxiety (2328); Discomfort (2330); Depression (2361); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is number 2 of 3 mdrs filed for the same patient (reference 0001822565-2017-04495 / 0001822565-2017-04497.Concomitant devices : palacos bone cement catalog # 00-1118-140-01, lot # 74704314, zimmer ankle tibial base size 3 catalog # 00450004300, lot number # 77003690, zimmer prolong tibial insert sz 3 +0 catalog # 00450005300, lot number # 62267028.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 a patient underwent a left ankle procedure.On the day of the procedure, mild tarsal/tibial neuritis was noted, and the patient underwent an injection approximately two (2) months post-operatively to treat the issue.This was reported to be not device related, but related to the procedure.Subsequently, mechanical signs of clicking and locking, an abnormal neurovascular assessment without functional limitation or pain, some problems with performing usual daily activities, some mobility issues, and moderate pain or discomfort were noted at six (6) week post-operative follow-up.Six (6) month post-operative follow-up noted: mild swelling, moderate tenderness, some mobility problems and some problems with performing daily usual activities, and severe pain/discomfort.At one (1) year post-operative follow, some mobility problems and problems with performing daily usual activities and severe pain/discomfort were noted.At two (2) year post-operative follow-up, some mobility problems and problems with performing daily usual activities and severe pain/discomfort were noted.Radiographic radiolucency was also noted at two (2) year post-operative follow-up.Attempts have been made to obtain additional information and further information is not available at this time.

Manufacturer Narrative

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

It was reported that a patient underwent a left ankle procedure.On the day of the procedure, mild tarsal/tibial neuritis was noted, and the patient underwent an injection approximately two (2) months post-operatively to treat the issue.This was reported to be not device related.Subsequently, mechanical signs of clicking and locking, an abnormal neurovascular assessment without functional limitation or pain, some problems with performing usual daily activities, some mobility issues, and moderate pain or discomfort were noted at six (6) week post-operative follow-up.Six (6) month post-operative follow-up noted: mild swelling, moderate tenderness, some mobility problems and some problems with performing daily usual activities, and severe pain/discomfort.At one (1) year post-operative follow, some mobility problems and problems with performing daily usual activities and severe pain/discomfort were noted.At two (2) year post-operative follow-up, some mobility problems and problems with performing daily usual activities and severe pain/discomfort were noted.Radiographic radiolucency that was related to the patient¿s medical condition, was also noted at two (2) year post-operative follow-up.

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 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 were trends identified.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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 BLUE SIZE 3 LEFT
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED
• 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: 6680674
• MDR Text Key: 78811382
• Report Number: 0001822565-2017-04496
• 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

• 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: 00450001300
• Device Lot Number: 77003664
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 09/26/2017; 10/13/2017
• Supplement Dates FDA Received: 10/03/2017; 10/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2014
• 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 Age: 71 YR
• Patient Weight: 73