MAUDE Adverse Event Report: ZIMMER, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Reaction (2414); No Information (3190)

Event Date 06/04/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: metasulâ® duromâ®, component for acetabulum, uncemented, 54/㸠48, code n/ pn 0100214054/ ln 2307987, metasulâ® ldhâ®, head, 48, code n, taper 18/20/ pn 0100181480/ ln 2301566, metasulâ® ldhâ®, head adapter, s, -4, taper 12/14-18/20/ pn 0100185145/ ln 2310327.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the product location being unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report that was filed by (b)(4): 0009613350-2017-00494.

Event Description

It was reported patient underwent right hip revision due to corrosion in the femoral head approximately three years post implantation.

Manufacturer Narrative

Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was able to be confirmed via the operative report.Device history record (dhr) was reviewed and no discrepancies were found.Review of complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

Additional information received in revision operative notes state that the patient was experiencing pseudotumor occupying the entire posterior interval behind the hip joint.The sciatic nerve was encased within the tumor and a 15-20% laceration was made through the sciatic nerve.In addition to the pseudotumor a lot of metallosis was noted at the junction between the femoral stem and the femoral head.The cup and head were removed.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6653936
• MDR Text Key: 78017265
• Report Number: 0001822565-2017-04250
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK161830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2015
• Device Model Number: N/A
• Device Catalogue Number: 00771101720
• Device Lot Number: 60313025
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2005
• 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): Hospitalization; Required Intervention
• Patient Age: 51 YR