MAUDE Adverse Event Report: ZIMMER, INC. MODULAR NECK A 12/14 NECK TAPER USE WITH +0 HEADS ONLY; HIP PROSTHESIS

Model Number N/A

Device Problems Corroded (1131); Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Pain (1994); Rash (2033); Reaction (2414)

Event Date 12/09/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 00620005420 shell porous with holes 61775734, 00625006540 self-tapping bone screw 61347347, 00630505036 polyethylene liner 61817121, 00625006535 self-tapping bone screw 61760636, 00771301200 modular femoral stem 61828115.

Event Description

It is reported that a patient was revised due to pain and rash.The surgeon believes that trunionosis caused these symptoms.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

Medical records state post operative diagnosis is trunnion corrosion with elevated cobalt and chromium levels.

Manufacturer Narrative

This follow up report is being submitted to report additional information.Reported was confirmed through review of medical records.Device history record (dhr was reviewed and no discrepancies relevant to the reported event 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.

• Brand Name: MODULAR NECK A 12/14 NECK TAPER USE WITH +0 HEADS ONLY
• 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: 6239118
• MDR Text Key: 64423091
• Report Number: 0001822565-2017-00058
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063251
• 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,Followup
• Report Date: 11/03/2017

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: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 00784801100
• Device Lot Number: 60819885
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2016
• Initial Date FDA Received: 01/10/2017
• Supplement Dates Manufacturer Received: Not provided; 11/03/2017
• Supplement Dates FDA Received: 02/16/2017; 11/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2007
• 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: 86 YR
• Patient Weight: 59