MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS 4CM DIAPHYSEAL SEGMENT; KNEE PROSTHESIS

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 04/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 150482 oss 4cm diaphyseal segment lot 012180, 178400 cps anchor plug 10mm lot 251130, 161041 oss rs non-mod plt long 71 lot 211290, 178526 cps transverse pin 6pk 28mm lot 259380, 150476 oss poly tibial bushing lot 528280, 178512 cps nut co-cr-mo alloy lot 606520, 150411 oss tibial poly bearing 14mm lot 772400, 150493 oss reinforced yoke lot 0000241415, 150478 oss poly lock pin lot 0000156857, 150480 oss axle lot 625130, 150477 oss poly femoral bushings 2pk lot 047020, 178742 cps mt xs spndl 400lb pins lot 707500, 178535 cps centering sleeve 13mm lot 319810, 150483 oss segmental stacking adapter lot 170860, 178710 cps taper locking cap / oss sc lot 396730, 178711 cps/oss 5cm tpr adapt w/oss sc lot 533150.Reported event was confirmed by review of x-rays provided.Xrays noted there is a small rounded metallic focus within hoffa's fat just anterior to the femoral component in the intra-articular hinge, possibly a loose body which would suggest implant disassembly.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 as no were trends identified.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 an orthopedic salvage procedure.Subsequently, the patient underwent a revision procedure approximately ten years post-implantation due to loosening of the last fixation screw through the femoral block of the distal femoral resection prosthesis.The surgeon was concerned that the loose screw was causing blockage of the knee joint and could possibly damage the metal prosthetic surface and articular surface.No additional patient consequences were reported.

• Brand Name: OSS 4CM DIAPHYSEAL SEGMENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7310498
• MDR Text Key: 101462192
• Report Number: 0001825034-2018-01639
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK002757
• 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
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 150482
• Device Lot Number: 012180
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2004
• 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
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Weight: 60