MAUDE Adverse Event Report: ZIMMER GMBH METASUL HEAD 40, 12/14, SIZE M/O

Catalog Number 00-8770-040-02

Device Problem Device Issue (2379)

Patient Problem Unspecified Infection (1930)

Event Date 03/11/2015

Event Type  Other  

Event Description

It was reported that due to osteonecrosis, the patient underwent a bilateral total hip arthroplasty.It was stated that during the surgery, the package of metasul head 40, 12/14, size m/0 was opened and was found that the inner packing material was tightly adhered tot the product.Then, surgeons opened another implant, which was prepared for the contralateral hip, unfortunately, the inner package was adhered tot the newly opened implant.As no replacement could be immediately transferred to the hospital, surgeon tried very hard to clean it up to continue the surgery.The implant was soaked in iodine after adhesion removed, then implanted into the patient.It took around 40 minutes to look for femoral heads replacement and do the cleaning up.It was also stated that after surgery, the patient appeared with infection symptoms and was under anti-infection treatment.

Manufacturer Narrative

The manufacturer did not receive devices or x-rays for review as the patient has not been revised.Three pictures were received.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 becomes available, that changes this assessment, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

• Brand Name: METASUL HEAD 40, 12/14, SIZE M/O
• Type of Device: METASUL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; wrsaw, IN 46581-0708 ; 5742676267
• MDR Report Key: 4711076
• MDR Text Key: 16563155
• Report Number: 9613350-2015-00435
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 04/02/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 00-8770-040-02
• Device Lot Number: 2655076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2015
• Initial Date FDA Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR