MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 60 REFOBACIN BONE CEMENT R; BONE CEMENT, ANTIBIOTIC

Catalog Number 4711500396-1

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 08/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: femur cemented posterior stabilized (ps) standard right size 7 with part# 42500606202, lot# 62988620; articular surface fixed bearing posterior stabilized (ps) right 10 mm height with part# 42521400710, lot# 62855821; tibia cemented 5 degree stemmed right size e with part# 42532007102, lot# 62988620.Report source, foreign event occurred in (b)(6).The device will not be returned to the manufacturer.Therefore it will not be analyzed.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

A persona ps knee cemented with optipac 60 refobacin bone cement r was implanted in 2015.The revision of the persona ps knee has been planned to take place on (b)(6) 2019 due to tibial loosening.The persona ps knee complaint is investigated in (b)(4).No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to correct information and to relay additional information.Item name : persona femur cemented posterior stabilized (ps) standard right size 7, item ref : (b)(4), item batch : 62755486.Item name : persona articular surface fixed bearing posterior stabilized (ps) right 10 mm height, item ref : (b)(4), item batch : 62855821.Item name : persona tibia cemented 5 degree stemmed right size e, item ref : (b)(4), item batch : 62988620.The reported event could be confirmed as the persona implant was returned, as stated in (b)(4).The device was not be returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.No similar complaints have been recorded for optipac 60 refobacine bone cement r, reference (b)(4), batch a427a03725.Within one year.The review of the patient medical records showed that the contributing factors of event were osteoarthritis and soft bone of the tibial plateau.X-rays and a picture of the implant and the cement concerning the reported event were received.The pictures analysis showed that the aspect of the cement anchoring in the bone was normal.Also, the pictures showed that there was a lack of cement on the right of the base plate picture which could be a cause of the loosening, this lack of cement is not related to the product but is related to the surgery.According to available data, the most probable root cause is due to the amount of cement implanted during the surgery.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions.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

It was reported that a persona ps knee cemented with optipac 60 refobacin bone cement r was implanted in 2015.The revision of the persona ps knee has been planned to take place on (b)(6) 2019 due to tibial loosening.Patient consent acquired for retrieval of the implants, however the product was discarded.No additional patient consequences were reported.The persona tibial element is investigated (b)(4).

• Brand Name: OPTIPAC 60 REFOBACIN BONE CEMENT R
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8978921
• MDR Text Key: 158603614
• Report Number: 3006946279-2019-00390
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 4711500396-1
• Device Lot Number: A427A03725
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 10/17/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 71