MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN OXFORD KNEE; PROSTHESIS, KNEE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Slipped (1584)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  malfunction  

Event Description

Martin, j.G.Et al.The knee.Vol.2, no.2, pp.121-125, 1995.Information was received based on review of a journal article entitled, "revision of unicondylar knee replacements to total knee replacement." it was reported that patient underwent an initial partial knee arthroplasty on an unknown date.Subsequently, patient was revised due to component loosening on an unknown date.All components were removed and replaced with a total knee.

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patients mentioned in the journal article.The article was written by martin jg et al.In the knee vol 2, no.2, 121-125, 1995.It is likely that these complications and revisions have already been reported; however, it cannot be determined based on the limited information made available in the article.Should additional information relating to the events be received, the updated information will be forwarded to the fda.This information was originally reported on 1825034-2015-03122 which referenced a journal article written on a study that this patient took part in.

Manufacturer Narrative

This supplemental report is being submitted to address only one event of the article.The following fields have been updated or corrected with additional/ updated information.(b)(6).Foreign: the event occurred in (b)(6).The product was not returned for evaluation due to unknown location.Reported event was unable to be confirmed as part number/lot number of device involved in the incident is unknown.Device history record (dhr) and complaint history review was unable to be performed as the lot/item number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation, under possible adverse effects: ¿loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ following review, no new risks were identified.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.This report is being submitted late as it has been identified in remediation.Product location unknown.

• Brand Name: UNKNOWN OXFORD KNEE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 4925762
• MDR Text Key: 21474445
• Report Number: 0001825034-2015-03141
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,foreign,health professi
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2017

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
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 07/20/2015
• Supplement Dates Manufacturer Received: 07/31/2017
• Supplement Dates FDA Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR