MAUDE Adverse Event Report: ZIMMER GMBH COCR HEAD 28/+4 'L' 12/14; UNKNOWN

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Pain (1994); Reaction (2414)

Event Date 09/25/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.The actual device is not marketed in usa, but devices with similar characteristics (i.E.Durasul cocr kopf 38/-8 'xs' 12/14 ref# 01.01012.384) are marketed in usa, and therefore this report was filed.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported that the patient was implanted a cocr head 28/+4 'l' 12/14 on (b)(6) 2015.Two months after the surgery, the patient experienced an allergic reaction (itches, burns and pain, first on the left leg and later on the whole body, from the top of the head to the little fingers from both feet and hands), which was later attributed to the prosthesis by the allergologist.

Manufacturer Narrative

A cause for this specific event cannot be ascertained from the information provided.Should additional information become available or an investigation result be available, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).Note: this is a split case with zimmer inc., (b)(4).

Event Description

It was reported that the patient was implanted a cocr head 28/+4 'l' 12/14 on (b)(6) 2015.This surgery was a revision of the thp due to an infection.Two months after the surgery, the patient experienced an allergic reaction (itches, burns and pain, first on the left leg and later on the whole body, from the top of the head to the little fingers from both feet and hands), which was later attributed to the prosthesis by the allergologist.

Manufacturer Narrative

Additional: if follow-up, what type? updates: date received by mfr, type of reports, evaluation codes, additional mfr narrative.A technical investigation was not possible to perform, as the devices were not at hand.However, based on the available information the investigation is conducted with outcome as follows.No trend was identified.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.It is reported that 2 months after the initial surgery, the patient experienced an allergic reaction (itches, burns and pain) the patient has a history as poliallergic to drugs, therefore it is assumed by the doctor that the patient is allergic to the material used in the prosthesis.It is requested by the surgeon from which material the product is made of.Two (2) undated x-rays were received for the investigation of the case; however, they are supposed to dated (b)(6) 2015 due to the file names.Both x-rays have low image quality, which makes the analysis difficult.X-ray of (b)(6) 2015 shows the left hip thr one day after the implantation surgery.The components look inconspicuous.However, no ap view x-ray was provided in order to be able to comment on the position of the devices.X-ray of (b)(6) 2015 shows the left hip thr 3 months after the implantation surgery.No abnormalities observed in terms of the components and bone condition.Surgical report and discharge notes, (b)(6) 2015: pre-operative diagnostic: septic complication of the prosthetic components.Post-operative diagnostic: aseptic loosening of the prosthetic components.Procedure: revision of the components on left hip.Implantation of the zimmer metabloc stem.Cemented, cup and head.Patient is discharged out of the hospital in good state and with good mobility.Review of product documentation: - "instruction leaflet for endoprostheses" was reviewed.This leaflet, which is available in the product packages, provides information about relevant contraindications, hazards, adverse effects, warnings, precautions, sterilization conditions as well as storage and handling of the device.¿allergy to the implanted material, above all to metal (e.G., cobalt, chromium, nickel, etc.)¿ is indicated as one of the contraindications in the leaflet.Moreover, it is stated under the warnings> preoperative section that ¿although allergies and other reactions to implant materials are unusual, they should be taken into consideration and excluded before surgery.¿ - general product labels of metabloc stem (cemented) and cocr head were reviewed.Material compositions of the devices are indicated below the item names in each implant sticker, which is available on the product packaging.According to those displayed labels, metabloc stem (cemented) is composed of protasul-s30 which includes the following elements: fe, cr, ni, mn, mo, nb, and n.Whereas cocr head consists of protasul-20 which includes co, cr, and mo as elements.(the elements are stated according to the decreasing amount from left to right.I.E.Fe has the highest amount in metabloc stem.) conclusion summary: metabloc stem (cemented) and cocr head are combined with zca all-poly acetabular cup in this complaint.According to the reported event the patient has a history as poliallergic to drugs and it is suspected by the surgeon that the patient might be allergic to the prosthesis she received.The elements that stem and head consist of are indicated under the investigation section.It is possible that the patient has allergy to one of those elements.However, it remains unknown to which element the patient is allergic.As it is indicated in the package insert ¿instruction leaflet for endoprostheses¿, allergies should be taken into consideration and excluded before surgery by the surgeon.Correct handling of the device is not under control of zimmer (b)(4).Based on the given information and the results of the investigation, we could identify a root cause for this issue.The root cause is non-indicated use of product.The need for corrective actions is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: COCR HEAD 28/+4 'L' 12/14
• Type of Device: UNKNOWN
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5887954
• MDR Text Key: 52490121
• Report Number: 0009613350-2016-01140
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: RO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• 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: 14.28.07-20
• Device Lot Number: 2804237
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2015
• 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: 68 YR
• Patient Weight: 72