MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN KNEE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Failure of Implant (1924); Sepsis (2067); Joint Dislocation (2374)

Event Type  Injury  

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" which assessed the efficacy of the oxford unicompartmental knee replacement.The study was conducted over a period of five (5) years (1987-1992) and involved twenty-three (23) patients who received twenty-three (23) knees.The journal article reports the following revisions by reason: sixteen (16) revisions due to loosening four (4) revisions due to meniscal dislocation three (3) revisions due to sepsis.The authors of the study conclude that the oxford unicompartmental knee has been shown to be a reliable option for the treatment of gonarthrosis in selected patients, with medium term results at least equaling those of total condylar replacements.This study demonstrates that when revision is necessary the results are generally good.The revision of unicondylar knees is technically easier to perform and the outcome is superior to revision of total condylar knees.

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.(b)(6).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.

Manufacturer Narrative

(b)(4).This report is being submitted late as it has been identified in remediation.This follow-up report is being submitted to relay additional information.Added age, checked "product problem", added additional information, added patient and device codes, added ¿health professional.¿, added manufacturer narrative (below).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot 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.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 Description

This complaint will address a (b)(6) patient who had loosening at follow-up after 20 months.

• Brand Name: UNKNOWN KNEE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 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: 4925678
• MDR Text Key: 20778699
• Report Number: 0001825034-2015-03122
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• 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?: Yes
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 52 YR