MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PALACOS R + G; BONE CEMENT, ANTIBIOTIC

Catalog Number 00-1113-140-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Renal Failure (2041)

Event Type  Injury  

Manufacturer Narrative

The event recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow-up mdr will be submitted.Device location unknown.

Event Description

It was reported that patient underwent revision of antibiotic bone cement spacer as patient developed symptoms of kidney failure.Due to the persistently elevated scr.No information received about the hospital.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Report source -.Nakasone, trisha & multani, ashrit & chary, aarthi & a.Renault, cybele & l.Winslow, dean.(2017).Acute kidney injury due to systemic absorption of antibiotics impregnated in a bone cement spacer: an underrecognized complication of a common intervention.Infectious diseases in clinical practice.26.1.10.1097/ipc.0000000000000575.The retrieval and review of the zimmer biomet receiving inspection report for 00111314001, lot number "unknown", was not conducted since the lot number is unknown.Heraeus batch records review could not be conducted since the lot number is unknown.Manufacturing and sterility dates could not be retrieved.Product examination was not performed as the product was not returned.This complaint is unconfirmed.Per heraeus, the root cause of the reported event is as follows: long term fate and behaviour of the bone cement in situ, knowledge and experience of surgeons: septic loosening, - infection.Long term fate and behaviour of the bone cement in situ, knowledge and experience of surgeons: septic loosening, - revision of the prosthesis.Heraeus notes that an explanation for "surgical site infection / hematogenous infection is ototoxicity and nephrotoxicity are very unlikely to be caused by the gentamicin of palacos r+g but rather by the added 9 g of vancomycin, 7.2 g of tobramycin as well as the systemic administered vancomycin dosed 15 to 20mg/l through day 20 and 2x 3 doses of 800 mg ibuprofen on day 5 and 6." the investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.H3 other text : product was not returned.

Event Description

It was reported that the patient then developed symptoms of kidney failure.Due to the persistently elevated scr, the acs was explanted, and a new, unknown prosthesis was implanted.The patient had nonoliguric acute kidney injury.An assessment revealed it was likely acute tubular necrosis.No additional event information available.

• Brand Name: PALACOS R + G
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8500719
• MDR Text Key: 141498981
• Report Number: 0001526350-2019-00232
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K031673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00-1113-140-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 57 YR