MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMT 360 TIB 5.0 OFFSET ADAPTER; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Swelling (2091)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: (b)(6) 2019.185203 - bmt 360 tib tray - 737710; 185305 - vg 360 dst fm ag - 115520; 183882 - vngd ssk psc tib brg - 246260; 185650 - bmt 360 tib sm cruciate - 727430; 148305 - bmt splined knee stm v2 - 731620; 185211 - bmt 360 tib 5.0 offset - 198190; 184764 - series a pat std - 693590; 148302 - bmt splined knee stm v2 - 139650; 185265 - vngd ssk 360 femur - 3366083; 00111214001 - palacos single - unknown; 00111214001 - palacos single - unknown; 00111214001 - palacos single - unknown.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.No medical records were provided.Medical records were provided and reviewed by a health care professional.Patient was revised with no complications noted.Post-revision ultrasound found soft tissue swelling and tendinosis without tear.Patient claims to have tested positive for infection but cannot be confirmed due to lack of medical records.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03370-4, 0001825034-2019-03372-4, 0001825034-2019-03373-4, 0001825034-2019-04217-3, 0001825034-2019-04218-3, 0001825034-2019-04219-3, 0001825034-2019-04233-3, 0001825034-2020-02312, 0001825034-2020-02315.
Event or Problem Description
It was reported that following a revision procedure, the patient experienced pain, swelling and falling.No additional patient consequences were reported.

• Brand Name: BMT 360 TIB 5.0 OFFSET ADAPTER
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10140279
• Report Number: 0001825034-2020-02314
• Device Sequence Number: 11342585
• Product Code: JWH
• UDI-Device Identifier: 00880304459519
• UDI-Public: 00880304459519
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K093293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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 Model Number: N/A
• Device Catalogue Number: 185211
• Device Lot Number: 233860
• 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: 06/04/2020
• Initial Report FDA Received Date: 06/10/2020
• 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 Age: 48 YR
• Patient Weight: 100