MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM EXTENSION 6MM OFFSET SPLINED UNCEMENTED 13MM DIA +135MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported initial right total knee arthroplasty on unknown date.Subsequently, patient had an aspiration due to crepitus.One month post aspiration had a knee arthroscopy with synovectomy due to pain.No records provided.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: 42504605812 femur cemented plus right size 5+, lot# 64705442, mdr: 0001822565-2022-03304; 42542006402 tibia fixed cemented right size c, lot# 64320247, mdr: 0001822565-2022-03306; 42522800414 articular surface fixed bearing constrained condylar knee rt 14 mm, lot# 64202796, mdr: 0001822565-2022-03307; 42560313514 stem extension 3mm offset splined uncemented 14mm dia +135mm, lot# 64769898, mdr: 0001822565-2022-03308; 42555803205 tibial augment cemented half block rt lateral size cd 5mm, lot# 64453271, mdr: 0001822565-2022-03309; 42555803405 tibial augment cemented half block right medial size cd 5mm, lot# 64353978, mdr: 0001822565-2022-03310.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  h6-component code- suggested code: mechanical g4-stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for the reported part and lot combination(s).Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pain was reported, taking nsaids for pain, physical therapy tolerated, knee aspirations were performed.The complaint of pain and noise could not be confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: STEM EXTENSION 6MM OFFSET SPLINED UNCEMENTED 13MM DIA +135MM
• 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: 15870948
• Report Number: 0001822565-2022-03305
• Device Sequence Number: 12076869
• Product Code: JWH
• UDI-Device Identifier: 00887868250279
• UDI-Public: (01)00887868250279(17)300720(10)64783534
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K181947
• 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): 02/23/2023

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: 42560613513
• Device Lot Number: 64783534
• 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: 02/22/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2020
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 82 KG