MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ORTHOPEDIC SALVAGE SYSTEM - OSS TIBIAL POLYETHYLENE BEARING 12; PROSTHESIS, KNEE

Catalog Number 150410

Device Problems Fracture (1260); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); No Information (3190)

Event Date 03/17/2017

Event Type  Injury  

Manufacturer Narrative

Reference: cmp(b)(4).Customer has not yet indicated if the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that following a knee arthroplasty, the patient's tibial bearing was revised due to fracture.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Concomitant medical product: -oss poly lock pin, catalog# 150478, lot# 010010; oss poly femoral bushings 2pk, catalog# 150477, lot# 558450; oss poly tibial bushing ,catalog# 150476, lot# 724250; cps short anchor plug 12mm, catalog# 178554, lot# 727370; cps transverse pin 6pk 32mm, catalog# 178527, lot# 355690; cps centering sleeve 14mm, catalog# 178536, lot# 529260; cps shrt 600# sm spindle ha, catalog# 178576, lot# 753300; cps nut co-cr-mo alloy, catalog# 178512, lot# 275130; cps/oss 5cm tpr adapt w/oss sc, catalog# 178711, lot# 643140; oss 11cm diaphyseal segment, catalog# 150468, lot# 203000; oss 7cm diahpyseal segment, catalog# 150466, lot3 169290; oss segmental stacking adapter, catalog# 150483, lot# 509310.

Manufacturer Narrative

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

Event Description

It was reported that following a knee arthroplasty, the patient's tibial bearing was revised due to fracture, pain, wear, and poor function of the knee.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product confirmed that the tibial bearing has fractured into two pieces.Sem analysis determined that the articular surface shows evidence of use with possible wear and burnishing.Bearing appears to have been loaded anteriorly, with evidence of possible degradation and delamination at locations on the anterior articular surface and edges of the bearing.The fracture surface was observed with little evidence for slow crack propagation.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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: ORTHOPEDIC SALVAGE SYSTEM - OSS TIBIAL POLYETHYLENE BEARING 12
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6527158
• MDR Text Key: 73866014
• Report Number: 0001825034-2017-02870
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2016
• Device Catalogue Number: 150410
• Device Lot Number: 334070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: Not provided; 03/13/2018; 03/19/2018
• Supplement Dates FDA Received: 06/09/2017; 03/19/2018; 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2011
• 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
• Patient Age: 20 YR