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 Problems Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 was reported that patient underwent initial a left knee arthroplasty on (b)(6) 2018.Subsequently, the patient experienced a deep infection on (b)(6) 2018.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products: femur cemented cruciate retaining (cr) standard left size 6, part# 42502606001; lot# 63702264.Natural tibia cemented 5 degree stemmed left size e, par# 42532007101; lot# 63917389.Articular surface fixed bearing cruciate retaining (cr) left 13 mm height, part# 42511000513; lot# 63583440.All poly patella cemented 32 mm diameter, part# 42540000032; lot# 63940181.

Event Description

It was reported that patient underwent initial a left knee arthroplasty on (b)(6) 2018.Subsequently, the patient experienced a deep infection on (b)(6) 2018.

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 investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that patient underwent initial a left knee arthroplasty on (b)(6), 2018.Subsequently, the patient experienced a deep infection on (b)(6) 2018.

Event Description

It was reported that a patient underwent initial left total knee arthroplasty on (b)(6) 2018.Subsequently, the patient experienced a superficial infection in the cicatrix (the scar of a healed wound).After antibiotic therapy, the cicatrix was documented clear of reaction (infection) at the 3 month follow up on (b)(6) 2018.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a2, b5, g4, h2, h6, h10.The event could be confirmed based on clinical information provided.The device will not be returned to the manufacturer.Therefore it could not be analyzed.The x-rays have been received.According to the resarch and development department, it was not possible to conclude if a deep infection was present based on the x-rays received.The review of the device manufacturing quality record indicates that 2327 products optipac-s 60 refobacin bone cement r, reference (b)(4), lot number a717c00225 were manufactured on 12 july 2017.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.The review of the sterilization certificate indicates that the products were sterilized according to the specification.No non conformity or deviation was observed which could be linked to the event described in the complaint.No other complaint has been recorded over the batch number within one year regarding infection.According to available data, the exact root cause can¿t 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.

• 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: 8539568
• MDR Text Key: 142747881
• Report Number: 3006946279-2019-00244
• 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,Followup,Followup
• Report Date: 10/25/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 4711500396-1
• Device Lot Number: A717C00225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 03/26/2019; 05/02/2019; 10/03/2019
• Supplement Dates FDA Received: 04/25/2019; 05/21/2019; 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 75