MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TRABECULAR METAL POROUS SHELL WITH CLUSTER HOLES; HIP PROSTHESIS

Model Number N/A

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 12/12/2016

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.Concomitant medical products - 00784802200 modular neck b 12/14 neck taper use with +0 heads only, 62720844.Concomitant medical products - 00771300500 modular femoral stem press-fit plasma sprayed cementless size 5, 61679608.This report is number 3 of 4 mdrs filed for the same patient reference;1822565-2017-00106; 2648920-2017-0012; 2648920-2017-00011; 1822565-2017-00106.

Event Description

It is reported a patient tripped and fell, she presented to the emergency room with a dislocated hip.The neck disassociated from the stem during the surgery to correct the dislocation.It was found that the acetabular component had become loose and was replaced as well.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.Op notes were evaluated and the reported event was confirmed.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Follow-up hip exam mentions dislocation of internal right hip prosthesis.The root cause of the reported issue is attributed to patient falling causing dislocation.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: ZIMMER TRABECULAR METAL POROUS SHELL WITH CLUSTER HOLES
• Type of Device: HIP PROSTHESIS
• 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: 6242949
• MDR Text Key: 64524549
• Report Number: 0001822565-2017-00106
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK093561
• 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: 12/15/2017

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 Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00620205022
• Device Lot Number: 62700582
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 01/11/2017
• Supplement Dates Manufacturer Received: 12/15/2017; 12/15/2017
• Supplement Dates FDA Received: 12/15/2017; 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2014
• 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: 57 YR
• Patient Weight: 61