MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER ML TAPER FEMORAL STEM

Catalog Number 00771300700

Device Problem Material Discolored (1170)

Patient Problem Pain (1994)

Event Date 04/13/2015

Event Type  Injury  

Event Description

It is reported the pt was revised due to pain.During the revision, significant fretting was found in the junction of the neck and stem.

Manufacturer Narrative

Review of the returned modular neck and stem confirmed that the neck exhibits discoloration/burnishing on the elliptical taper.Similar discoloration was observed on the mating internal taper of the stem.Additional damage found on the modular neck most likely occurred during the removal/extraction from the mating stem.Fretting is not uncommon in modular device with mechanical interference fit, as observed in the returned device.Review of the device history records did not find any deviations or anomalies.The records show the elliptical taper is 100% inspected on coordinate measuring machine (cmm) and found to be conforming to print specifications.The eval of the returned neck at the neck to stem elliptical taper, identified fretting on the surface area of approximately 15% which has a goldberg score of 2, a mild severity of corrosion with less than 30% of the taper surface discolored or dull.Non-destructive testing was performed via radiography and dye penetrant testing, finding no cracks in the device.It was determined that an indication on the surface was due to a smear or folded metal.As stated previously, the neck and stem were 100% inspected via cmm at the time of mfr.These devices were used for treatment.Compatibility of the returned devices was reviewed with no issues noted.Surgical notes were not provided.It is unk whether the components were implanted with the correct fit and orientation as per the surgical technique.Pt factors that may affect the performance of the components such as bone quality, type of activity (low impact vs.High impact), and relevant medical history are unk.A specific root cause cannot be determined with the info provided.

• Brand Name: ZIMMER ML TAPER FEMORAL STEM
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4780226
• MDR Text Key: 17202437
• Report Number: 1822565-2015-00720
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 00771300700
• Device Lot Number: 62059079
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• 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
• Treatment: ZIMMER M/L KINECTIV NECK, CATALOG #00784801401,; LOT# 60757549
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 125