MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 52 MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Osteolysis (2377)

Event Date 11/12/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer head cat#00801803602 lot#61138086, zimmer liner cat#00630505036 lot#61049361, zimmer cup cat#00620205222 lot#61132699, zimmer stem cat#00771300700 lot#60825861, zimmer neck cat#00784801201 lot#60850265.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 medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 03886, 0002648920 - 2018 - 00587, 0001822565 - 2020 - 00102.

Event Description

It was reported patient underwent left hip revision approximately 6 years post implantation due to recurrent dislocations.During the procedure it was noted implant wear, acetabulum osteolysis and necrosis.The liner, head and neck were revised.No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, b5, g4, g7, h2, h3, h6, h10.The event was confirmed with medical records received.Primary op notes were reviewed and no complications were noted.Revision op notes were reviewed and identified grooving of acetabular rim from dislocations.Soft tissue necrosis debrided.Liner exchange, femoral head and modular neck exchange.Acetabular osteolysis.No osteolysis noted at femoral component.Dhr was reviewed and no discrepancies relevant to the reported event were found.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.

Event Description

No further event information available at the time of this report.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 52 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9568529
• MDR Text Key: 174273527
• Report Number: 0001822565-2020-00102
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• PMA/PMN Number: K093561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 00620205222
• Device Lot Number: 61132699
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other