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

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Reaction (2414); Fluid Discharge (2686)

Event Date 08/29/2014

Event Type  Injury  

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 product(s): versys femoral head, p/n 00801803202, l/n 60769399; modular femoral stem, p/n 00771300500, l/n 60762669; trilogy acetabular system liner, p/n 00631005032, l/n 60773415; modlular neck, p/n 00784801400, l/n 60778058; trilogy screw, p/n 00625006525, l/n 60771748; trilogy liner, p/n 00631005032, l/n 60773415; trilogy shell, p/n 00620005422, l/n 60798022; trilogy bone screw, p/n 00625006525, l/n 60808931.Multiple mdr reports were filed for this event.Please see associated reports: 2648920-2014-00254, 0001822565-2016-02723, 0001822565-2017-03250.

Event Description

It is reported that the patient was revised following a hip arthroplasty due to pain.During the procedure, metal debris, corrosion, fluid effusion, pseudotumor formation, and liner impingement were noted.The femoral head, neck and acetabular liner were removed and replaced.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of op notes provided.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Revision operative record noted a pseudo tumor around the right hip.The patient was stated to be hypercobaltemic.On incision the capsule tissue was noted to be thickened with surface appearance consistent with cobalt chrome metallosis.No gross metal staining of the tissue was noted.Taper corrosion was confirmed on the head and stem trunnion.The elevated liner was noted to have an impingement defect from the femoral neck.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No device was received for examination.Reported event was unable to be confirmed due to limited information received from the customer.However, liner fracture and femoral head female taper debris and damage was noted.Dhr was reviewed and no discrepancies were found.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

No further information available.

• Brand Name: KINECTIVE TECHNOLOGY MODULAR NECK
• 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: 6578756
• MDR Text Key: 75595188
• Report Number: 0001822565-2017-03250
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK99508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/30/2018

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: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 00784801400
• Device Lot Number: 60778056
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 05/19/2017
• Supplement Dates Manufacturer Received: Not provided; 10/28/2017; 11/29/2018
• Supplement Dates FDA Received: 06/13/2017; 10/30/2017; 12/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2007
• 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: 69 YR
• Patient Weight: 77