MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL POROUS WITH CLUSTER HOLES 56 MM O.D.; PROSTESIS, HIP

Catalog Number 00620005622

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Information (3190)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation is completed, a follow-up mdr will be submitted.Concomitant medical products; item# unk/ unk stem/ lot # unk, item# unk/ unk screw/ lot # unk, item# unk/ unk head / lot # unk, item# unk/ unk liner/ lot # unk.

Event Description

It was reported patient underwent hip revision approximately 11 years post implantation for cup loosening.Cup was removed during revision attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

D11: item# unknown/unknown screw/ lot # unknown.Item # unknown /unknown screw /lot # unknown.Item# 00630505636/ liner/ lot# 61028686.Item # unknown /unknown ceramic head /lot # unknown.Item # unknown /unknown stem/lot # unknown.Reported event was to be confirmed product return.Analysis of product indicated bio-debris on the fibermetal coating of the cup.No other damage was identified.One of the two screws were fractured.It's unknown if the screw fractured in vivo or upon removal.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2020 -01288, 0001822565 -2020 -01289.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 56 MM O.D.
• Type of Device: PROSTESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 9349926
• MDR Text Key: 167315915
• Report Number: 0002648920-2019-00849
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2018
• Device Catalogue Number: 00620005622
• Device Lot Number: 61079422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention