MAUDE Adverse Event Report: ZIMMER, INC. - BUILDING 5 DURASUL BIPOLAR INSERT; PROSTHESIS, HIP

Model Number N/A

Device Problem Compatibility Problem (2960)

Patient Problem No Information (3190)

Event Date 03/23/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the surgeon implanted a liner with an incompatible shell.A revision surgery is planned.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Concomitant medical product - bipolar acetabular shell catalog#: 00440500044 lot#: 63083209, femoral stem catalog#: 00786401100 lot#: 63180108, femoral head catalog#: 00801802602 lot#: 63250971.Reported event was unable to be confirmed.Dhr review of lot 62929067 indicates the devices were manufactured and packaged to specifications.Inspection and packaging documentation shows all devices that were accepted, completed, and sent to inventory met specifications.Dhr review shows no deviations to the standard manufacturing process.Dhr shows no anomalies or deviations that would have affected the surgical outcome or contributed to the reported event.Review of complaint history determined that no further action is required as no trends were identified.Root cause of the reported event can be attributed to improper implant selection.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: DURASUL BIPOLAR INSERT
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER, INC. - BUILDING 5; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC. - BUILDING 5; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5594852
• MDR Text Key: 43227343
• Report Number: 0001822565-2016-01255
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 440526042
• Device Lot Number: 62929067
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: 08/28/2017
• Supplement Dates FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2015
• 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): Other
• Patient Age: 74 YR