MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PALACOS RG 1X40 SINGLE; PALACOS R+G 1X 40G SINGLE (WITH GENTAMICIN)

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

The product will not be returning to the manufacturer for evaluation as it is an internal component, however a follow up medwatch will be submitted once the investigation is complete.

Event Description

It was reported that the patient had a left total knee arthroplasty on (b)(6) 2015.Subsequently, the patient is concern about a possible allergic reaction.

Manufacturer Narrative

It was reported that the patient had a left total knee arthroplasty on (b)(6) 2015.Subsequently, the patient is concern about a possible allergic reaction.No product fault was reported by the customer on this complaint.This was a request for information relevant to allergic reactions.The palacos cement is an original equipment manufacturers (oem) product produced by heraeus medical.Zimmer biomet is the licensed distributor for this product line in the united states.A supplier field complaint information request (scir) was forwarded to heraeus medical on this complaint.The response to that scir is as follows: we would like to refer to your inquiry about information on potential allergic or sensitivity reactions to ingredients of pmma bone cements.From the literature and our own long-term observations there have been very rarely cases of allergic reactions in patients to individual components of pmma bone cement (cf.Thomas etal, 2008 ¿allergy to bone cement components¿).Cured bone cements from heraeus medical have been studied in accordance with din en iso 10993-10 (2003-02): biological evaluation of medical devices part 10: ¿tests for irritation and sensitization¿ and generally show no sensitizing potential.Cured palacos bone cements can contain very small amounts of benzoyl peroxide, hydroquinone, n, n-dimethyl-p-toluidine, methyl methacrylate, chlorophyll, zirconium dioxide, and in gentamicin-containing bone cements, also gentamicin sulfate.An allergy testing (skin patch test) for individual cement components can easily be misinterpreted and/or even cause an allergy.Therefore, we recommend to address open questions to the ¿working group on allergy and immunological aspects of the implant material incompatibility¿ (allergomat): http://allergomat.Klinikum.Uni-muenchen.De/en/ recommended actions: no additional zimmer biomet actions warranted at this time.

• Brand Name: PALACOS RG 1X40 SINGLE
• Type of Device: PALACOS R+G 1X 40G SINGLE (WITH GENTAMICIN)
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: david bailey ; 200 west ohio avenue; dover, OH 44622 ; 3303438801
• MDR Report Key: 5708755
• MDR Text Key: 46885399
• Report Number: 0001526350-2016-00056
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00111314001
• Device Lot Number: 81984446
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR