MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL WITH CLUSTER HOLES POROUS 48 MM O.D. SIZE GG FOR USE WITH GG LINERS; PROSTHESIS, HIP

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Information (3190)

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were submitted for this event.Please see reports: 0001822565 - 2017 - 08631, 0001822565 - 2017 - 08633, 0001822565 - 2017 - 08634.(b)(4).Concomitant medical products: 00875200932, liner elevated rim 32 mm o.D.Size hh for use with 50 mm o.D.Size hh shell, lot 63725435; 00875304801, shell with cluster holes porous 48 mm o.D.Size gg for use with gg liners, lot 63421517; 00875305001, shell with cluster holes porous 50 mm o.D.Size hh for use with hh liners, lot 63598550; 00875305001, shell with cluster holes porous 50 mm o.D.Size hh for use with hh liners, lot 63379166.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a procedure the cup could not be stabilized and a liner could not be impacted after several attempts.This event has caused 90 minutes delay.No further information has been made available at this time.

Manufacturer Narrative

Cmp-(b)(4).This follow-up report is being submitted to relay additional information.Updated: complaint sample was evaluated and the reported event was confirmed.Product was returned for evaluation.As returned, device show damages from the failed attempts to install.Device history record dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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.

Manufacturer Narrative

The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a right hip procedure the cup could not be stabilized.The liner would not seat after impacted, the liner was removed, cleaned, dried, and implanted again, the liner would not seat completely.The cup was taken out impacted on the operating table, still would not seat.The surgeon tried implanting a new cup, the liner would not seat in the cup after trying several times.Finally, the surgeon had to remove the cup and screws and use a new larger cup and correspond liner to complete the surgery.This event has caused 90 minutes delay.

• Brand Name: SHELL WITH CLUSTER HOLES POROUS 48 MM O.D. SIZE GG FOR USE WITH GG LINERS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7148281
• MDR Text Key: 96045623
• Report Number: 0001822565-2017-08632
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PK151448
• 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,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• 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: 00875304801
• Device Lot Number: 63421517
• Other Device ID Number: (01)00889024150133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2016
• 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: 66 YR
• Patient Weight: 45