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 Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Distress (2329); Unspecified Tissue Injury (4559)

Event Date 06/01/2022

Event Type  Injury  

Event Description

Patient received a primary bilateral tha to treat arthrosis in both femoral heads, for this reason, surgery was recommended as a matter of urgency.Hip prosthesis implantation surgery was performed in (date removed).In less than 6 months experienced strong pain with noise in the hip joint, when investigating, it was found that the left side liner had fractured.The left hip head and liner were revised.

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: (b)(6).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Hto.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic evidence confirmed, the reported allegation.The acetabular liner was found, fracture into multiple pieces.However, there is not enough evidence to determine, if audible sound could be caused by the acetabular liner and another device.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the ceramic inserts belongs to the shop order (b)(4).Protocols and acceptance certificate were reviewed.The quality documents show, that the data obtained on the ceramic inserts confirmed, to the specification valid at the time of production.The component properties and the microstructure as obtained from the quality documents fulfill the requirements, as specified at the time of production.There is no indication of any pre-existing material defect.Device history review: a manufacturing record evaluation was performed, for the finished devices [121881754 /9830552] and [121881754 /9798196] numbers.And no non-conformances / manufacturing irregularities were identified, during manufacturing.

• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17184041
• MDR Text Key: 317720023
• Report Number: 1818910-2023-12799
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121881754
• Device Lot Number: 9798196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CORAIL2 STD SIZE 13; DELTA CER HEAD 12/14 36MM +5; EA DELTA CER INSERT 36IDX54OD; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE SECTOR II CUP 54MM
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male