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

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Reaction (2414)

Event Date 02/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 00620206022, trabecular metal shell with cluster holes, 60544339; 00630506038, trilogy highly crosslinked poly liner, 60339665; 00625006535, self tapping bone screw, 60687783; 00625006530, self tapping bone screw, 60671314; 00625006525, self tapping bone screw, 60206294.The device will not be returned for analysis as it remains implanted; however an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event.Please see associated report: 0002648920-2017-00187.

Event Description

It was reported that the patient had a hip revision due to elevated ion levels approximately 10 years post implantation.The patient was being treated for bilateral bursitis with steroid injections approximately 6 months and a year prior to the revision.Patient stated only injection relieved symptoms for 2 months after each injection.Lab results showed elevated cobalt and chromium levels.Operative notes determined that intraoperatively that there was no adverse tissue response.All information available has been obtained.

Manufacturer Narrative

This follow up report is being submitted to report additional information.Reported revision was unable to be confirmed due to insufficient information, however, medical records provided show the patient was experiencing pain and elevated ion levels prior to the revision date.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.A definitive root cause cannot be determined with the information provided 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

It was reported that the patient had a hip revision due to elevated ion levels approximately 10 years post implantation.The patient was being treated for bilateral bursitis with steroid injections approximately 6 months and a year prior to the revision.Patient stated only injection relieved symptoms for 2 months after each injection.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER
• Type of Device: HIP PROSTHESIS
• 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: 6394487
• MDR Text Key: 69559356
• Report Number: 0001822565-2017-01633
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK161830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

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: Physician
• Device Expiration Date: 11/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 00771101120
• Device Lot Number: 60572311
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: 02/20/2018
• Supplement Dates FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2006
• 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: 78 YR
• Patient Weight: 69