MAUDE Adverse Event Report: ZIMMER, INC. APR HIP SYSTEM HOODED ENHANCED ACETABULAR INSERT; PROSTHESIS, HIP

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 04/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date implanted - an unknown date in 1997.Concomitant medical products - unknown head, unknown stem, apr cup 51mm/ pn 431100051/ ln 1268571.

Event Description

It was reported that patient underwent a revision due to poly wear approximately twenty years post implantation.A cup, head, and liner exchange took place.

Manufacturer Narrative

This follow up report is being filed to relay corrected and additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No devices were received.Photos were received, the visual evaluation of the photos cannot determine the condition of the device.Device history record 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.There are warnings in the package insert that this type of event can occur and associated risks are addressed in risk documentation.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: APR HIP SYSTEM HOODED ENHANCED ACETABULAR INSERT
• 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: 6535046
• MDR Text Key: 74113389
• Report Number: 0001822565-2017-02692
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK954800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 433828051
• Device Lot Number: 1240185
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/1996
• 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