MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 40MM +3 HIWALL LNR SZ24; PROSTHESIS, HIP

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Information (3190)

Event Date 03/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were reported for this event.Please also see associated events: 0001825034 - 2018 - 02364, 0001825034 - 2018 - 02366, 0001825034 - 2018 - 02367.Concomitant medical products: pt-106056 regen/rnglc+ multi 56mm sz 24 lot 752890, ep-108524 e-poly 40mm +3 hiwall lnr sz24 lot 168940, 16-116054 rnglc+ ltd hole shell sz54 lot 720230.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the acetabular liner would not lock into the acetabular cup, resulting in a delay of 1-2 hours.Attempts have been made and no further information has been made available.

Manufacturer Narrative

The follow up report is submitted to relay additional information received: udi: (b)(4).The liner was returned but it is unknown which one of the two was returned.Complaint sample was evaluated and the reported event was confirmed.Both shells and one liner were returned and evaluated.Upon visual inspection the liner was damage around the scallops.Both shells show no visible damages.Dimensional analysis on the shells were conforming to print specifications.Dimensional analysis on the liner cannot be performed due to its impaction and resulting damage.The other liner was not returned.The device history records were reviewed and no related deviations/ anomalies were identified that affect the reported event.A definite root cause cannot be determined with information available.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: E-POLY 40MM +3 HIWALL LNR SZ24
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7416626
• MDR Text Key: 105143841
• Report Number: 0001825034-2018-02365
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• PMA/PMN Number: PK090103
• 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: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/15/2022
• Device Model Number: N/A
• Device Catalogue Number: EP-108524
• Device Lot Number: 925850
• Other Device ID Number: (01) EP-108524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Date Manufacturer Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR