MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM EXTENSION 3MM OFFSET SPLINED UNCEMENTED; 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); Numbness (2415)
Date of Event	04/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: femur cemented plus right size 7+, item # 42504606212, lot # 64566646, tibia fixed cemented right size e stem extension, item # 42542007102, lot # 64318491, stem extension tapered cemented, item # 4256000751,4 lot # 64630443, tibial augment cemented half block, item # 42555805405, lot # 64499789, unknown articular surface, item # unknown lot # unknown.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2022-03311, 0001822565-2022-03313, 0001822565-2022-03314, 0001822565-2022-03315 and 0001822565-2022-03316.Device remains implanted.
Event or Problem Description
It was reported patient is experiencing pain, bursitis and tendonitis four months post implantation due to a fall.Radiographically, implants remain intact, in stable position, and with no evidence of loosening or wear.Attempts to obtain additional information have been made; however, no more is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Mechanical (g04) - stem.Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates that office visit had a few falls and is now having pain, x-ray: no acute fractures or dislocations, implant remain in good position.X-rays: stable position, no loosening or wear, was falling once a week, steroid injection for pes bursitis, knee pain improved but now has back pain, 60 percent improvement with knee pain, rom: 0-125 degree, tenderness to midline joint, immediate discomfort with extension, mild swelling.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: STEM EXTENSION 3MM OFFSET SPLINED UNCEMENTED
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15868475
• Report Number: 0001822565-2022-03312
• Device Sequence Number: 20135901
• Product Code: MBH
• UDI-Device Identifier: 00887868250071
• UDI-Public: (01)00887868250071(17)291031(10)64578342
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

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: 42560313517
• Device Lot Number: 64578342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 91 KG