MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VGXP XP E1 TIB BRG RM 9X71; PROSTHESIS, KNEE

Model Number	N/A
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2021-02050, 0001825034-2021-02051, 0001825034-2021-02053, 0001825034-2021-02054.Medical product: vgxp xp inlk pri tib tray 75mm, item# 195757, lot# 920620.Series a pat thin 37x8.6 3 peg, item# 184788, lot# 510690.Vgxp xp e1 tib brg rl 9x71, item# 195779, lot# 865300.Vgxp intlk femoral rt 70 item# 195912 lot# 917030 report source- (b)(6).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 that a patient is experiencing moderate pain, stiffness, and constant swelling of the knee two years post implantation.The patient self-treats with ice packs, physical therapy, and pain relievers and continues to remain active.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: six weeks; no complications, rom 10-110°, mild flexion contracture / extension lag.No ambulatory aids.One year; no complications, some problems, mild-moderate pain, little difficulty.Private pt, oral pain relievers prn.Two years; no complications, some problems, moderate pain.Private pt, pain relievers, stiffness, constant swelling - treated with ice packs.Ae; approximately two years and three month¿s post implantation; unexplained pain - seen by team over last two years.Felt normal recovery.Medial pain continues.Had ct scan + u/s scan - showed less than 2mm lucency tibial component - no treatment - see in six months.Still playing golf + walking good distances.- radiolucency is not being called out as a complaint category as it is less than 2mm and remains unchanged with no complications such as reported loosening.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: VGXP XP E1 TIB BRG RM 9X71
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12165397
• Report Number: 0001825034-2021-02052
• Device Sequence Number: 11759503
• Product Code: MBH
• UDI-Device Identifier: 00880304552555
• UDI-Public: (01)00880304552555(17)191006(10)865300
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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 Expiration Date: 10/06/2019
• Device Model Number: N/A
• Device Catalogue Number: 195849
• Device Lot Number: 865300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Weight: 86