MAUDE Adverse Event Report: ZIMMER GMBH ALLOCLASSIC SL STEM 3 12/14; ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL

Catalog Number 2843

Device Problem Metal Shedding Debris (1804)

Patient Problem Pain (1994)

Event Date 05/14/2015

Event Type  Injury  

Event Description

It was reported that the pt was implanted a alloclassic sl stem 3 12/14 on (b)(6) 2013.The pt was revised on (b)(6) 2015.The pt complained about pain, during the revision surgery it was found that the proximal stem was slightly relaxed.A large amount of dry and crumbly metallosis and wear between the neck and head were also found.

Manufacturer Narrative

The manufacturer did not receive devices or other source documents for review.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 info provided.Should add'l info become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer's reference #: (b)(4).

Manufacturer Narrative

According to the received information, the retrievals at hand were revised after 1 year and 11 months in vivo due to loosening of the stem.On the ap x-ray at hand, labeled preoperative, the proximal two thirds of the stem seem to be loose while the distal end is fixed in the cortical bone.This is reflected first by the description in the surgical report and second by the appearance of the stem at hand.Bone attachments were found only on the stem's distal end.It is reported that during revision surgery signs of metallosis were found in the proximal part of the stem.The operative pictures at hand do not show greyish stained tissue pointing to metallosis known as a local accumulation of metal particles in the tissue.The surgical report states that a thin black threadlike structure was seen at the neck-head interface.Signs of fretting corrosion could be found on the head taper.It is possible that the above mentioned structure could be a result of the fretting corrosion.One influencing factor to the latter phenomenon is the mounting of the head on the stem taper.A suboptimal mounting could lead to such phenomenon.Based on the given information and the results of the investigation, it was not possible to identify a specific root cause for the reported event.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

• Brand Name: ALLOCLASSIC SL STEM 3 12/14
• Type of Device: ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; po box 708; winterthur, IN 46581-0708 ; 5742676131
• MDR Report Key: 4820654
• MDR Text Key: 5837369
• Report Number: 9613350-2015-00640
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 2843
• Device Lot Number: 2690461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 100