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

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

J bone joint surg [br] 1998; 80-b: 876-82 psychoyios, v., et al.Information was received based on review of a journal article titled, "wear of congruent meniscal bearings in unicompartmental knee arthroplasty: a retrieval study of 16 specimens" which aimed to determine the penetration rates of similar bearings used in medial unicompartmental replacement using the oxford, manufactured at biomet.The study was conducted over a period of ten (10) years (1983 and 1993) and involved sixteen (16) patients who received sixteen (16) knees.The journal article reports the following revisions by biomet brand name and reason: six (6) revisions due to pain, four (4) revisions due to pain caused by progression of arthritis in the lateral compartment, two (2) revisions due to tibial component loosening, one (1) revision due to femoral and tibial component loosening, one (1) revision due to bearing dislocation, one (1) revision due to bearing dislocation and femoral component loosening, one (1) revision due to tibial component loosening and stress fracture.The authors of the study conclude that in unicompartmental arthroplasty using congruent meniscal bearings, linear polyethylene wear is negligible, and is not influenced by the thickness of the polyethylene from 3.5 to 11.5 mm.Great care is needed at implantation to avoid impingement of the bearing against bone or cement, since this leads to accelerated wear and may contribute to failure.

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 psychoyios v et al.In j bone joint surg br.1998 nov;80(6):976-82.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.The following sections were updated: added product problem, added additional patient 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

There has been no further information provided and the patient outcome is unknown.

• 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: 4945772
• MDR Text Key: 6256827
• Report Number: 0001825034-2015-03339
• 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: 10/26/2017

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?: Yes
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 07/28/2015
• Supplement Dates Manufacturer Received: 08/08/2017
• Supplement Dates FDA Received: 10/26/2017
• 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