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

Model Number N/A

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

Patient Problems Death (1802); Unspecified Infection (1930); Pain (1994); Ambulation Difficulties (2544); No Code Available (3191)

Event Type  Injury  

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 sherman kp et al.In j r soc med.1985 nov;78(11):916-9.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.

Event Description

Journal of the royal society of medicine volume 78 november 1985.Sherman, k.P., et al information was received based on review of a journal article titled, "bilateral oxford meniscal knee arthroplasty" which, followed 32 patients who underwent bilateral bicompartmental oxford knee arthroplasty for a mean period of 51 months from the time of their first operation between 1976 and 1983.Pain relief was obtained in all but one knee; walking ability was improved in more than two-thirds.Overall patient satisfaction with the results was good.Two knees failed.One patient died unrelated causes.The mean follow up from the time of the first operation was 4 years and 3 months and the mean interval between operations on the two sides was 10.5 months.The mean follow up following completion of the second operation was 3 years and 4 months.Two knees, out of the total of 64, failed during the period of this study - one became infected and was successfully arthrodesed, and the other was converted at 52 to a competitor knee following aseptic loosening of components.Two further knees were successfully revised following aseptic loosening; one of these had all the components revised, and the other had just the lateral tibial component replaced.One displaced prototype meniscus was replaced at 20 months with no subsequent problems.In all but one knee significant pain relief was obtained, and in no case was there any increase in pain at follow up.Only 2 patients had any subjective feeling of instability in the knees at follow up, despite an average preop varus-valgus instability of 16 degrees, reduced to less than 2 degrees postop.Walking ability was improved in 23 patients and unchanged in 9.Two patients were disappointed.In conclusion, the severe disability of bilateral arthritis of the knees can usually be relieved by arthroplasty.The oxford meniscal knee components restored stability and range of motion safely and without extensive invasion of the bones.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information: the following sections were updated: report type, added additional information, catalog and lot number, patient and device codes, manufacturer narrative.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 events: ¿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.

Event Description

An unknown patient was identified in the article that underwent a revision 28 months post-op due to aseptic loosening; all components were replaced.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): 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: 4997568
• MDR Text Key: 22819030
• Report Number: 0001825034-2015-03586
• 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
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 07/20/2015
• 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