MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMT 360 7.5MM OFFSET ADAPTER; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 148291 - bmt splined knee stm v2 16x40 ¿ 999910, 141355 - rgx 3 peg ser a patella 28mm ¿ 528570, 148301 - bmt splined knee stm v2 11x80 ¿ 739010, 183808 - vngd ssk psc tib brg sm 18x59 ¿ 546740, 185536 - vg 360 oti tib slv sm half b ¿ 602200, cp116182 - ti p aug 57.5 rt 360 fmrl ¿ 117060, 185212 - bmt 360 7.5mm offset adapter - 947060, cp116184 - cus ti por 59 360 tib tray - 117070.No devices were received; therefore the condition of the components is unknown.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined; however, it was confirmed a screw for the offset adapter contains nickel.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 02013, 0001825034 - 2019 - 02014, 0001825034 - 2019 - 02015, 0001825034 - 2019 - 02016, 0001825034 - 2019 - 02017, 0001825034 - 2019 - 02018, 0001825034 - 2019 - 02019.
Event or Problem Description
It was reported that the patient began experiencing pain, burning, and difficulty ambulating approximately 3 years after knee revision surgery.

• Brand Name: BMT 360 7.5MM OFFSET ADAPTER
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9616324
• Report Number: 0001825034-2020-00364
• Device Sequence Number: 14122643
• Product Code: JWH
• UDI-Device Identifier: 00880304483019
• UDI-Public: 00880304483019
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2025
• Device Model Number: N/A
• Device Catalogue Number: 185212
• Device Lot Number: 947060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 43