MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) RIGHT; 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); Swelling/ Edema (4577)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2021-02741, 0001822565-2021-02742.Concomitant medical product: femur trabecular metal posterior stabilized (ps) standard porous, item# 42500807002, lot# 64558536.Natural tibia trabecular metal two-peg porous fixed bearing right size g, item# 42530007902, lot# 64193675.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient experienced increased pain and swelling one day post implantation and returned for an emergency fasciotomy due to compartment syndrome.The patient was discharged home three days after the operation and demonstrated improvement in pain and function through the six-month follow up.There is no additional information available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.It was reported that a patient experienced compartment syndrome and underwent an emergency fasciotomy the day after total knee arthroplasty.Compartment syndrome occurs when swelling within the muscle and soft tissues places stress on the fascia which is inflexible to maintain structure.As the swelling increases, this can cause severe pain and pressure in the area which can lead to nerve and tissue damage resulting in parasthesia.Acute compartment syndrome requires an emergency fasciotomy or cutting into the fascia so that the swelling can resolve and prevent permanent nerve and tissue damage.Postoperative joint swelling is a localized swelling or inflammation which is described as an accumulation of fluid in the interstitium, the space between cells, located beneath the skin and in cavities of the body.Inflammation from surgical trauma causes the release of moderators called cytokines.Swelling may increase during activities or when sitting or standing in one position for an extended period.Swelling or inflammation is the body¿s natural response to heal damaged tissue postoperatively.According to the aaos, mild to moderate swelling is a normal and expected finding for three to six months following surgery.Severe swelling is not considered an expected finding.The swelling and procedure-related complication of compartment syndrome required emergency intervention to prevent permanent impairment and was the result of the controlled trauma of surgery.After the fasciotomy, the patient recovered without further complication.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device history records will not be performed.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: ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) RIGHT
• 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 ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12520098
• Report Number: 3007963827-2021-00209
• Device Sequence Number: 4460187
• Product Code: JWH
• UDI-Device Identifier: 00889024241190
• UDI-Public: (01)00889024241190(17)270831(10)64271842
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42521401011
• Device Lot Number: 64271842
• 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: 09/01/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 138 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White