MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 60 REFOBACIN BONE CEMENT R-3; BONE CEMENT, ANTIBIOTIC

Catalog Number 4711500396-3

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: metaphyseal sleeve porous; item #: 1294-54-000; lot #: j04d82.Sigma femoral posterior stabilized cemented; item #: 1960-40-400; lot #: 8181392.Tibial tray rotating platform; item #: 1294-35-140; lot #: j0523n.Tibial tray rotating platform - stabilized; item #: 96-2144; lot #: 8107297.P.F.C.Sigma femoral adapter; item #: 96-0781; lot #: j2524w.P.F.C.Sigma distal augment: item #: 96-0880; lot #: 717084.P.F.C.Sigma posterior augment: item #: 96-0880; lot #: h5398.P.F.C.Sigma femoral adapter bolt; item #: 96-0784; lot #: j1986f.P.F.C.Sigma femoral adapter bolt; item #: 86-6402; lot #: d19011746.Report source, foreign - event occurred in (b)(6).The investigation is in process, once the investigation has been completed, a follow-up mdr will be submitted.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 has been reported that the patient had initial implant on (b)(6) 2016 and on (b)(6) 2017 the patient was revised.

Manufacturer Narrative

(b)(4).H3 - device not evaluated as not involved in the event.As per operative notes review, the device optipac 60 refobacin bone cement r-3 with item # 4711500396-3 and lot # 836ba09225 was implanted on (b)(6) 2019, and was not revised.There is no adverse event recorded involving the optipac 60 refobacin bone cement r-3 with item # 4711500396-3 and lot # 836ba09225 implanted on (b)(6) 2019.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 the patient underwent an initial surgery on (b)(6) 2016 due to progressive disabling gonarthrosis of the left knee.Persona prosthesis and refobacin bone cement ref 3003960001 batch a549cg3003 were implanted.Patient underwent revisions on (b)(6) 2017 and (b)(6) 2017 due to infection.Persona implants were removed, and refobacin bone cement ref 3003960001 batch a549cg3003 remained implanted.On (b)(6) 2019, patient underwent revision due to partial loosening of the femoral component.The prosthesis was replaced by a pfc prosthesis and the refobacin bone cement ref 3003960001 batch a549cg3003 was replaced by optipac.

• Brand Name: OPTIPAC 60 REFOBACIN BONE CEMENT R-3
• 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: 8707115
• MDR Text Key: 148273046
• Report Number: 3006946279-2019-00289
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04040029922361
• UDI-Public: (01)04040029922361
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 07/01/2019

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: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 4711500396-3
• Device Lot Number: 836BA09225
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 07/21/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR