MAUDE Adverse Event Report: ZIMMER TMT TM CRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT: YELLOW, SIZE 3 C-H, 17MM; TM MONOBLOCK TIBIAL COMPONENT

Catalog Number 00588604317

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

Patient Problems Muscular Rigidity (1968); Tissue Damage (2104)

Event Date 10/18/2017

Event Type  Injury  

Manufacturer Narrative

A review of the implant's manufacturing record indicates that it was manufactured to specification.Based on the information available, the root cause of the event cannot be determined.Should additional information be obtained to further this investigation, this report shall be updated.Parts will not be released by hospital.

Event Description

It was reported that the patient had primary surgery on (b)(6) 2017 and had a revision surgery on (b)(6) 2017 due to joint stiffness, patient had previous manipulations under anaesthetic and had more flexion, this again became stiff hence why revision was completed.Soft tissue releases around joint space were conducted, this allowed flexion of approximately 90 plus degrees.The implants were then removed and the new implants were implanted.Part number 00-5886-043-17; lot: 62280556; tm monoblock tibial component is the only tmt design controlled part.

• Brand Name: TM CRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT: YELLOW, SIZE 3 C-H, 17MM
• Type of Device: TM MONOBLOCK TIBIAL COMPONENT
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: william hara ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 7028027
• MDR Text Key: 91957808
• Report Number: 3005751028-2017-02733
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK031462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 00588604317
• Device Lot Number: 62280556
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2013
• 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): Required Intervention