MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED POSTERIOR STABILIZED(PS) STANDARD LEFT SZ 11; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Fall (1848)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
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 and mdrs: 42532007501 tibia cemented 5 degree stemmed left size f lot# 64786843, mdr: 3007963827-2021-00219.42511400811 articular surface fixed bearing posterior stabilized (ps) left 11 mm height lot# 64455491, mdr: 3007963827-2021-00220.
Event or Problem Description
It was reported a patient underwent an initial left total knee arthroplasty.Three weeks postop, the patient fell due to unknown reasons resulting in surgical wound dehiscence.The patient underwent an exploration and debridement of the wound which confirmed the dehiscence remained superficial and did not impact the joint below the fascia.In subsequent follow ups, the patient reported no additional problems and demonstrates satisfactory progress.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Fall due to unknown reasons resulting in additional surgical procedure for wound dehiscence.Dehiscence is a partial or total separation of previously approximated wound edges.In this event the patient had a traumatic dehiscence of the inferior portion of the midline surgical incision as a result of the fall.No evidence of infection, contamination, or further complications were noted.The patient subsequently progressed well without any revision of product or further intervention.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: FEMUR CEMENTED POSTERIOR STABILIZED(PS) STANDARD LEFT SZ 11
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; .; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12532309
• Report Number: 3007963827-2021-00218
• Device Sequence Number: 5847110
• Product Code: JWH
• UDI-Device Identifier: 00889024229297
• UDI-Public: (01)00889024229297(17)300331(10)64640052
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42500607001
• Device Lot Number: 64640052
• 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: 09/02/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male