MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN CR-FLEX ARTICULAR SURFACE SIZE GREEN C-H 10 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number 00595204010

Device Problem Pitted (1460)

Patient Problem Pain (1994)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: nexgen cr-flex gsf porous femoral component, item #: 00575201602, lot #: 63209214; nexgen stemmed precoat tibial component, item #: 00598004701, lot #: 63278108; nexgen standard all poly patella size 26 mm diameter 7.5 mm thickness, item #: 00597206526, lot #: 62510474.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event.Please see associated report: 0002648920 - 2017 - 00277.

Event Description

It was reported that following a total knee arthroplasty, the patient underwent an articular surface and patella revision due to pain.The articular surface appeared to have foreign body wear from cement.The patella was removed and bone overhang was cleared.Attempts have been made and additional information on the reported event is unknown.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.However, pictures of the tibial articular surface were provided for further evaluation.The device has wide spread pitting across the entirety of the articulating surface with foreign material imbedded into the surface.Device history record was reviewed and no discrepancies 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.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.

• Brand Name: NEXGEN CR-FLEX ARTICULAR SURFACE SIZE GREEN C-H 10 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: 6541918
• MDR Text Key: 74356087
• Report Number: 0001822565-2017-02961
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK003910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 00595204010
• Device Lot Number: 63189983
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention