MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL DISTAL FEMORAL AUGMENT BLOCK; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)
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 decice 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.00549003410 trabecular metal distal femoral augment block lot# 63322074.Mdr- 3005751028-2020-00099.00545001730 trabecular metal femoral diaphyseal cone, 30mm lot# 63392061.Mdr- 3005751028-2020-00101.00544705336 nexgen lcck tm coupled tibial cone, a/p wedged size 3 lot# 62380724.Mdr- 3005751028-2020-00102.
Event or Problem Description
It was reported she has been encountering pain, swelling, inflammation, and difficulty walking and exercising since her revision surgery.She also stated she had a metal allergy test done, which determined she is highly allergic to nickel and cobalt chromium.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history record(s) for item/lot [00549003410/63141884] identified no deviations or anomalies during manufacturing.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Review of complaint history identified 1 additional similar complaints for the reported item (00549003410) - the additional product on this same complaint- and no additional complaints for the reported part and lot combination (00549003410/63141884).Complaints are monitored through monthly complaint review (reference os 5017) in order to identify potential adverse trends.Medical records were not provided.A field action search using cognos bi identified no quality hold with an r-code as the reason associated with the following part/lot combinations (00549003410/63141884) as of 7-jan-2020.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

• Brand Name: TRABECULAR METAL DISTAL FEMORAL AUGMENT BLOCK
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 10895707
• Report Number: 3005751028-2020-00100
• Device Sequence Number: 16895310
• Product Code: JWH
• UDI-Device Identifier: 00889024309487
• UDI-Public: (01)00889024309487
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K040487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00549003410
• Device Lot Number: 63141884
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/11/2021
• 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
• Outcome Attributed to Adverse Event: Other