MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 04/26/1999

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: unknown liner.Once the investigation has been completed, a follow up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-03792.

Event Description

It was reported that patient underwent a right hip revision approximately one year post implantation due to disassociation of the poly liner from acetabular shell.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

(b)(4).The following report is submitted to relay additional information.Concomitant medical products: unk head lot#unk item#unk, unk stem lot#unk item#unk, unk harris-galante porus ii cup item#unk lot#unk.The complaint is confirmed by op notes address that the superior aspect of the femoral head had undergone collapse with fragmentation.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-03792 0001822565-2017-06912, 0001822565-2017-06914.

Manufacturer Narrative

The following report is submitted to relay additional and corrected information.

Event Description

It was reported that patient underwent a right hip revision approximately 11 years post implantation due to disassociation of the poly liner from acetabular shell.

• Brand Name: UNKNOWN LINER
• 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: 6609496
• MDR Text Key: 76590074
• Report Number: 0001822565-2017-03793
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• 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: 10/11/2017

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2017
• Initial Date FDA Received: 06/02/2017
• Supplement Dates Manufacturer Received: 10/11/2017; 10/11/2017
• Supplement Dates FDA Received: 10/11/2017; 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 54 YR