MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR CEMENTED; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: tibia fixed stem extension, catalog # 42542007102, lot # 65503331.Articular surface fixed bearing constrained condylar knee (cck), catalog # 42522800612, lot # 64615548.Stem extension offset splined uncemented, catalog # 42560613512, lot # 65645041.Stem extension offset splined uncemented, catalog # 42560613514, lot # 65703571.Tibial augment cemented half block, catalog # 42555805405, lot # 65085595.Tibial augment cemented half block, catalog # 42555805205, lot # 65102663.Mri sterile short osteotome blade 12mm, catalog # 47996602122, lot # 56715440.H3: 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: 0001822565-2023-01817, 0001822565-2023-01818, 0001822565-2023-01819, 0001822565-2023-01820, 0001822565-2023-01821, 0001822565-2023-01822.
Event or Problem Description
It was reported patient is experiencing ambulation difficulties, pain, swelling, redness in knee post implantation.Attempts to obtain additional information have been made; however, no more is available at this time.
Event or Problem Description
Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
Correction: h6 upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
Event or Problem Description
It was reported patient is experiencing ambulation difficulties, pain, swelling, redness in knee post implantation.It was further reported that the patient's pain levels are out of control, and they cannot walk unassisted.There is a future arthroscopy planned.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.It was previously reported on mfr#: 0001822565-2023-01816-1 that this event was considered non-reportable on behalf of zimmer biomet.However, upon receipt of additional information, it has been determined that report#: 0001822565-2023-01816-1 was drafted and submitted erroneously.This event remains reportable as it has been indicated the patient has suffered a serious injury.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10 this complaint has been confirmed by the presence of nickel.The additional information received does not change the previous investigation.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.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (04) femur.Visual examination of the provided picture identified the patient as having swollen lower legs and ankles.No product was returned, or pictures of the products provided.Review of the device history records identified no deviations or anomalies during manufacturing.Compatibility of the devices was reviewed with no issues noted.Medical records were provided and reviewed by a healthcare professional.Review of the available records identified that the patient was experiencing pain, swelling, ambulation difficulties, and could not walk unassisted due to pain.A definitive root cause could not be determined.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: FEMUR CEMENTED
• 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: 17269619
• Report Number: 0001822565-2023-01816
• Device Sequence Number: 5774043
• Product Code: JWH
• UDI-Device Identifier: 00889024562684
• UDI-Public: (01)00889024562684(17)320920(10)65604351
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/30/2023

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: 42504605812
• Device Lot Number: 65604351
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 06/29/2023; 08/01/2023; 11/01/2023; 11/27/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 07/25/2023; 08/10/2023; 11/14/2023; 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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