MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EA DELTA CER INSERT 36IDX54OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number 121881754

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problems Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Surgeon called from the st.Alexis hospital today and said that a patient who received our endoprosthesis with a ceramic-ceramic friction pair about five years ago had a split in the ceramic insert.Details will be available tomorrow after alexander's visit to the clinic.The doctor suggests a potential problem with product quality.".

Manufacturer Narrative

Product complaint # :(b)(4).Investigation summary
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> no device associated with this report was received for examination.A review of device manufacturing records found no related deviations or anomalies.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot
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> lot 7928506.The quality documents show that the values obtained on the ceramic liner are according to specifications valid at the time of production.Device history review
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> the quality documents show that the values obtained on the ceramic liner are according to specifications valid at the time of production.

• Brand Name: EA DELTA CER INSERT 36IDX54OD
• Type of Device: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10358127
• MDR Text Key: 201878949
• Report Number: 1818910-2020-17388
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 121881754
• Device Lot Number: 7928506
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORAIL2 STD SIZE 14; DELTA CER HEAD 12/14 36MM +1.5; EA DELTA CER INSERT 36IDX54OD; PINNACLE SECTOR II CUP 54MM