MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE PROSTHESIS, KNEE

Catalog Number 00588006014

Device Problems Material Erosion (1214); Appropriate Term/Code Not Available (3191)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

The follow-up report is being submitted to relay additional information. Concomitant medical product: nexgen all polyethylene patella, cat#: 00597206535 lot#: 62793817, nexgen rotating hinge knee femoral, cat#: 00588001601 lot#: 62502480, nexgen straight stem extension, cat#: 00598801012 lot#: 37215178, nexgen tibial tray, cat#: 00588000600 lot#: 62788361, nexgen straight long stem extension, cat#: 00598801114 lot#: 00370899. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-01631, 0002648920-2017-00685, 0001822565-2017-07706.

Event Description

It was reported the patient underwent a total knee arthroplasty. Subsequently, the patient underwent a revision procedure approximately two years post-implantation due to locking knee and hyperextending joint. It was indicated that the problem could be a result of damage to the hinge pin. The surgeon indicated that during the revision the pin was noted to be loose. He also noted that there was wear of the polyethylene bearing and the patella button. No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was confirmed by x-ray review. X-ray review states that left total knee arthroplasty complicated by damaged anterior tilted hinge pin and metallosis. Possible contributing factor to hinge pin malalignment is malalignment of the tibial component which lacks desirable posterior slope. However, the wear of the device can't be observed via x-ray. 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. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. 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.

Event Description

It was reported the patient underwent a total knee arthroplasty. Subsequently, the patient underwent a revision procedure approximately two years post-implantation due to locking knee and hyperextending joint. It was indicated that the problem could be a result of damage to the hinge pin. The surgeon indicated that during the revision the pin was noted to be loose. He also noted that there was wear of the polyethylene bearing and the patella button. Metallosis was found by third party x-ray review. No additional patient consequences were reported.

Manufacturer Narrative

(b)(6). Implant date - it was reported that it was approximately two years ago. (b)(4). It is unknown if product will be returning to zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient is scheduled for a revision due to a locking knee and hyperextending joint. It was indicated the problem might be due to damage to the hinge pin.

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
• 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: 6392222
• MDR Text Key: 120143873
• Report Number: 0001822565-2017-01631
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PK013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 00588006014
• Device Lot Number: 62207488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/09/2017 Patient Sequence Number: 1