MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS MOD EXPANDABLE SZ20 SEG; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Local Reaction (2035); Joint Swelling (2356)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Implanted on unknown day in (b)(6) 2010.Concomitant medical products: unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a left limb salvage procedure.Subsequently, patient underwent a revision surgery to remove an unknown rod approximately 9 years post-implantation due to pain and swelling.During the revision black tissue around the rod was noted.Attempts have been made and no additional information is available at this time.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.X-rays were provided and reviewed by a healthcare professional.No findings were available due to poor quality.It was confirmed the patient experienced metallosis; however, we could not confirm the device failed.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Concomitant medical products : oss axle; p/n: 150480, l/n: 478830, stryker bone cement; p/n: 6191-1-001, l/n: rfq139, stryker bone cement; p/n: 6191-1-001, l/n: rfq139, oss non-mod tib plate short 75; p/n: 161042, l/n: 755500, cps anchor plug 14mm; p/n: 178404, l/n: 794540, cps transverse pin 6pk 40mm; p/n: 178529, l/n: 400660, oss poly femoral bushings 2pk; p/n: 150477, l/n: 067100, oss tibial poly bearing 12mm; p/n: 150410, l/n: 010460, oss poly lock pin; p/n: 150478, l/n: 275680, oss 7cm segmental femoral lt; p/n: 150355, l/n: 610950, cps lg h f spindle 12mm pc ha; p/n: 178504, l/n: 533050, cps nut co-cr-mo alloy; p/n: 178512, l/n: 778690, cps centering sleeve 16mm; p/n: 178538, l/n: 367360, oss reinforced yoke; p/n: 150493, l/n: 478850, oss poly tibial bushing; p/n: 150476, l/n: 499260, oss mod expandable sz20 seg; p/n: cp111234, l/n: 840040.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

No further event information available at the time of this report.

• Brand Name: OSS MOD EXPANDABLE SZ20 SEG
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8699712
• MDR Text Key: 148021751
• Report Number: 0001825034-2019-02587
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K002757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: N/A
• Device Catalogue Number: CP111234
• Device Lot Number: 840040
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 08/05/2019; 02/19/2020
• Supplement Dates FDA Received: 08/30/2019; 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 25 YR
• Patient Weight: 65