MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN ROTATING HINGE KNEE TIBIAL COMPONENT PRECOAT SIZE 2 PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Ossification (1428); No Code Available (3191)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: item name: femoral component cemented size c right, item number: 00588001302, lot number: 61077463. Item name: prc agmt block dist sz c 5mm, item number: 00599003310*op1000, lot number: 60969421. Item name: prc agmt block dist sz c 5mm, item number: 00599003310*op1000, lot number: 61173797. Item name: articular surface hinge post extension size c 14 mm, item number: 00588003014, lot number: 61091165. Item name: stem extension sharp fluted 11mm dia x 75mm length, item number: 00598801511, lot number: 607885156. Item name: stem extension straight long 14mm dia x 155mm length(combined length 200mm), item number: 00598801114, lot number: 60372674. Report source:- (b)(6). No product was returned. Visual and dimensional evaluations could not be performed. Device history record (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. Based on the information available, a definitive root cause cannot be determined. 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: 0001822565-2017-05573, 0001822565-2017-05576, 0001822565-2017-05575, 0001822565-2016-04777.

Event Description

It was reported that patient was revised due to a fracture of the femoral shaft approximately seven years post implantation. X-rays indicated slight anterior displacement of the distal femoral component, osseous radiolucency of lateral femoral condyle, radiolucency at the tibial tray, tibial stem shows loosening, and generalized osteopenia and heterotopic ossifications.

• Brand Name: NEXGEN ROTATING HINGE KNEE TIBIAL COMPONENT PRECOAT SIZE 2
• 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: 6779011
• MDR Text Key: 82402624
• Report Number: 0001822565-2017-05576
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2014
• Device Model Number: N/A
• Device Catalogue Number: 00588000200
• Device Lot Number: 61170223
• Other Device ID Number: N/A
• 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: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2009
• 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: 08/09/2017 Patient Sequence Number: 1