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

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Device Slipped (1584)

Patient Problems Cyst(s) (1800); Pain (1994)

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, "the oxford medial unicompartmental arthroplasty" which aimed to report the ten-year survival of knees with anteromedial osteoarthritis and normal acls treated by unicompartmental replacement using the oxford prosthesis, manufactured at biomet.It was reported that patient underwent a partial knee arthroplasty on an unknown date.Subsequently, patient was revised due to pain on an unknown date ten years following the initial procedure.Operative findings noted femoral loosening and a subchondral cyst during the procedure.All components were removed and replaced with a total knee.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Date of event - unknown.Expiration date - unknown.Date implanted - unknown.Date explanted - unknown.Initial reporter - the article was written by murray dw, goodfellow jw, o'connor jj in j bone joint surg br.1998 nov;80(6):983-9.Pma/510(k) number.Manufacture date ¿ unknown.This information was originally reported on 1825034-2015-02956 which referenced a journal article written on a study that this patient took part in.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed as part number and lot number of the device involved in the incident is unknown.Device history record 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.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.Murray, d.W.¿the oxford medial unicompartmental arthroplasty.¿ the journal of bone and joint surgery, 80-b, no.6, nov.1998, pp.983¿989.(b)(4).

Event Description

Revision due to pain and loosening.

• 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: 4901626
• MDR Text Key: 6540099
• Report Number: 0001825034-2015-02901
• 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: 12/14/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN KNEE
• 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: 06/18/2015
• Initial Date FDA Received: 07/09/2015
• Supplement Dates Manufacturer Received: 06/18/2015
• Supplement Dates FDA Received: 12/15/2017
• 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