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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Cyst(s) (1800)

Event Date 08/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Concomitant medical products: femoral component part#: 10507544; lot# 63615614; tibial baseplate component part#: 10507544; lot# 63804052; tibial articulating surface part#: 10507544; lot# 63890778; patella part#: 10507544; lot# 63804252.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient received an initial cemented implant on (b)(6) 2018 on the left knee.On (b)(6) 2018 the patient experienced a ruptured baker¿s cyst which has impacted function of the knee, especially in flexion.The patient suffers of asteoarthritis, recurrent ovarian cancer and lymphoedema of both legs, worst in the left leg.

Event Description

It has been reported that the patient received an initial cemented implant on (b)(6) 2018 on the left knee.On (b)(6) 2018 the patient experienced a ruptured baker¿s cyst which has impacted function of the knee, especially in flexion.The patient suffers of asteoarthritis, recurrent ovarian cancer and lymphoedema of both legs, worst in the left leg.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Medical product : femoral component item#: 42502006401 ; lot# 63615614.Tibial baseplate component item#: 42532007101; lot# 63804052.Tibial articulating surface item#: 42512100810; lot# 63890778.Patella item#: 42540000032; lot# 63804252.The device will not be returned to the manufacturer.Therefore it will not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.With the available information, the exact root cause of the event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The device will not be returned to the manufacturer.Therefore it will not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.With the available information, the exact root cause of the event could not be determined.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 received an initial cemented implant on (b)(6) 2018 on the left knee.On (b)(6) 2018 the patient experienced a ruptured baker¿s cyst which has impacted function of the knee, especially in flexion.The patient suffers of asteoarthritis, recurrent ovarian cancer and lymphoedema of both legs, worst in the left leg.

Event Description

It has been reported that the patient received an initial cemented implant on (b)(6) 2018 on the left knee.On (b)(6) 2018 the patient experienced a ruptured baker¿s cyst which has impacted function of the knee, especially in flexion.The patient suffers of asteoarthritis, recurrent ovarian cancer and lymphoedema of both legs, worst in the left leg.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The device was not 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.The investigation concluded that the ruptured baker's cyst was not related to the implantation of the device.Indeed, the surgeon stated that the baker's cyst was pre existing and it was due to the osteoarthritis.The most probable root cause of the event is the state of the patient.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.

• Brand Name: OPTIPAC-S 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: 8522274
• MDR Text Key: 142190426
• Report Number: 3006946279-2019-00242
• 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,study
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 4711500396-1
• Device Lot Number: A713D07305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 95