MAUDE Adverse Event Report: ZIMMER, INC. ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 14 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Range of Motion (2032); Swelling (2091); Claudication (2550)

Event Date 11/03/2013

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).This report is number 4 of 4 mdrs filed for the same patient (reference 0001822565-2016-03948-1, 0001822565-2016-04708, 0001822565-2016-04709, and 0001822565-2016-04710).

Event Description

Patient reported experiencing limited range of motion, limping, pain, swelling, tibial and shin pain and tibial component subsiding.Patient was prescribed physical therapy but was non-compliant.No revision has been reported.

Manufacturer Narrative

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.

• Brand Name: ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 14 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• 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: 6182932
• MDR Text Key: 62669656
• Report Number: 0001822565-2016-04710
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 42512200414
• Device Lot Number: 62277091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2013
• 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: 54 YR
• Patient Weight: 114