MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL FEMORAL DIAPHYSEAL CONE 30MM, SM LT; 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); Loss of Range of Motion (2032); Swelling/ Edema (4577)
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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products $ mdrs: 00545001336 trabecular metal tibial cone, med 36x31mm lot# 62038927 mdr: 3005751028-2022-00003.
Event or Problem Description
It was reported the patient underwent a left hip revision.Two years after the most recent revision, the patient presented with pain over the pes anserine bursa, swelling, stiffness, and a decrease in flexion.Labs and a bone scan were ordered, but no further information or report of intervention has been provided at this time.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.The device history records were reviewed for deviations and/ or anomalies with no anomalies/ deviations related to the event identified.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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: 1st follow up- doing well with pt, ambulating with a cane.Minimal swelling, rom 10-100 --2nd follow up- some pain and swelling, doing very well with pt, patient happy with rom but frustrated with pain.No complications on xray.--3rd follow up- patient was doing well, pain 1/10 until a week ago.'she was walking across her yard and she stepped in a weird position, heard a pop, and had really bad pain to the inferior pole of her patella.Notices more popping and locking and the knee feeling like it wants to give out.Patient denies falling or hitting the knee when this happened.' she likely has some soft tissue swelling and maybe a grade i tear over the capsule.Nothing that would need surgery at this point.-- 1yr follow up- patient reports constant chronic pain in the medial portion of the knee.No complications on xray.Surgeon satisfied with patient progress --2yr follow up- patient reports worsening knee pain, denies injuries or falls.Rom 0-120*, no complications on xray.Patient prescribed 1 time pt session lengthen the it band, surgeon feels patient may have left trochanteric bursitis which is compounding pain --current- patient presents with pain, swelling, and stiffness, rom 0-95*, sharp stabbing pain over pes bursa.No complications on xray, labs and bone scan ordered, no results provided 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.

• Brand Name: TRABECULAR METAL FEMORAL DIAPHYSEAL CONE 30MM, SM LT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: william hara ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 13506226
• Report Number: 3005751028-2022-00002
• Device Sequence Number: 4063563
• Product Code: JWH
• UDI-Device Identifier: 00889024308381
• UDI-Public: (01)00889024308381(17)210630(10)63392061
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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 Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00545001730
• Device Lot Number: 63392061
• 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: 01/17/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2016
• 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
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic