MAUDE Adverse Event Report: ZIMMER, INC. KINECTIVE TECHNOLOGY MODULAR NECK; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Reaction (2414); No Information (3190); Metal Related Pathology (4530)

Event Date 06/22/2016

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

Legal counsel for patient states patient underwent a revision for unknown reasons approximately seven years post-implantation.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-01444, 0002648920-2017-00189, 0002648920-2017-00190, 0001822565-2017-01464.Concomitant medical products: shell porous with cluster holes 52 mm catalog#: 00620205222 lot#: 61079134.Femoral head sterile product do not resterilize 12/14 taper catalog#: 00801803602 lot#: 61138084.Liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells catalog#: 00630505036 lot#: 61112271.Modular femoral stem press-fit plasma sprayed cementless size 17.5 catalog#: 00771301700 lot#: 60862168.Reported event was confirmed through review of medical records.After reviewing operative notes, it was confirmed that metallosis and metal debris were found in patient's tissue.Trunnionosis was observed as well.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were 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.

Event Description

It was reported that a patient underwent right hip revision surgery approximately 7 years post primary surgery, due to metallosis and trunnionosis.During the surgery, metal debris were found in patient's soft tissue.All implants were removed and competitor's parts were implanted.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent right hip revision surgery approximately 7 years post implantation.During the revision there was metallosis, metal debris in the soft tissue and trunnions at the femoral neck modular junction.No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the patient had a right hip arthroplasty.The patient was revised due to metallosis and trunnionosis at the femoral neck junction.Trochanteric osteotomy utilized to excise the femoral component, wire was placed distal to the osteotomy for stabilization, cerclage wires were utilized for osteotomy after final component in place.Additional information does not change the root cause of previous investigation.

• Brand Name: KINECTIVE TECHNOLOGY MODULAR NECK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• MDR Report Key: 6375882
• MDR Text Key: 69014407
• Report Number: 0001822565-2017-01449
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: PK063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/12/2021

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: 06/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 00784802300
• Device Lot Number: 60969507
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: Not provided; 10/17/2017; 09/15/2021; 10/11/2021
• Supplement Dates FDA Received: 03/09/2017; 10/19/2017; 09/28/2021; 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR