MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER SEGMENTAL SYSTEM POLYETHYLENE INSERT SIZE C; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Naturally Worn (2988)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: medical products-headless trocar drill pin catalog# 00590102000 lot# 62938286, nexgen straight stem ext 12mm dia x 145mm,(100mm) catalog# 00598801012 lot# 62465942, nexgen rotating hinge stem tibial plate, size 2 catalog# 00588000200 lot# 62754632, nexgen rh knee tm 10mm full blk tib agmt, sz 2 catalog# 00588002210 lot# 62154786, segmental art surf, sz c, 14mm catalog# 00585003014 lot# 63011037, segmental knee poly insert, size c catalog# 00585001395 lot# 63098034, segmental distal femur, size c-rt catalog# 00585001302 lot# 63030057, segmental tm collar, for 9-16mm, 35mm catalog# 00585204035 lot# 62852863, segmental str fluted stem, 13x130mm catalog# 00585205013 lot# 62811367.Customer has indicated that the product will not be returned to zimmer biomet for investigation due to device being still implanted in the patient.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 reports: 0001822565-2016-04564-1 and 05061.

Event Description

It has been reported that following a total knee arthroplasty revision, the patient is experiencing hyper-extension.It is currently unknown if the patient will be revised.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Radiolucent lines present at the tibial component cement bone interfaces are suspicious for loosening of the tibial component.However, bone detail is limited.The distal tibial stem is excluded from the lateral radiographs.Mild lateral subluxation of the patella, with scalloped remodeling articular surface of the lateral patellar facet at contact with the arthroplasty lateral condyle.X-rays confirm hyperextension; however, do not show cause for hyperextension or instability.The root cause for this issue was determined to be a design deficiency a summary of the investigation has been sent to the complainant.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.

Manufacturer Narrative

Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.3 other text : product location is unknown.

Event Description

It is now reported that the patient underwent a revision on an unknown date.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Radiolucent lines present at the tibial component cement bone interfaces are suspicious for loosening of the tibial component.However, bone detail is limited.The distal tibial stem is excluded from the lateral radiographs.Mild lateral subluxation of the patella, with scalloped remodeling articular surface of the lateral patellar facet at contact with the arthroplasty lateral condyle.X-rays confirm hyperextension; however, do not show cause for hyperextension or instability.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.The root cause for this issue was determined to be a design deficiency a summary of the investigation has been sent to the complainant.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.

• Brand Name: ZIMMER SEGMENTAL SYSTEM POLYETHYLENE INSERT SIZE C
• 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: 6731694
• MDR Text Key: 80659604
• Report Number: 0001822565-2017-05061
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00585001395
• Device Lot Number: 63098034
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2015
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Weight: 59