MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY MODULAR FEMORAL STEM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Host-Tissue Reaction (1297)
Date of Event	07/11/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Concomitant medical products: versys hip system femoral head , p/n 00801803602; kinectiv technology modular neck g, p/n 00784802300; zimmer m/l taper hip prosthesis with kinectiv technology modular femoral stem, p/n 00771301000; trident cluster acetabular shell p/n 542-11-54f; trident x3 0 polyethylene insert p/n 623-00-36f.Multiple mdr reports were filed for this event.Please see associated reports: 0001822565-2017-03760, 0001822565-2017-03761 and 0001822565-2017-03762.
Event or Problem Description
It was reported that patient underwent a revision procedure five years post-implantation due to implant corrosion and adverse local tissue reaction with a pseudotumor and trunionnosis.Operative notes report the patient had corrosion between the neck and the head.A large amount of blackened tissue surrounding the taper junction on the trunnion was identified.Furthermore, corrosion products were identified within the taper junction of the femoral head itself.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.Upon receipt of additional information of the reported event, it was determined that this device is not reportable as it was not involved in the event and did not malfunction.This report should be voided.

• Brand Name: ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY MODULAR FEMORAL STEM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• MDR Report Key: 6604024
• Report Number: 0001822565-2017-03762
• Device Sequence Number: 995392
• Product Code: KWA
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: PK063251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2018

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
• Operator of Device: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00771301000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 11/03/2017; 05/22/2018
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 11/03/2017; 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention