MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 12; HIP FEMORAL STEM

Model Number L20312

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Joint Laxity (4526); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle pfs and medical records received.Pfs alleges pain, sleeping disturbance, discomfort right leg, hip, walking difficulty and instability.Miss out work due to hip pain, surgery and recovery.Plaintiff is seeking compensation for all the injuries and financial losses.After review of the medical records the lab result mri hip reported there was a streak artifact despite metal artifact reduction.There is a mild atrophy of the right iliopsoas and hamstring tendinopathy.Mild degenerative arthrosis of the symphysis pubis and pubalgia.Cobalt and chromium result were below 7 ppb.Doi: (b)(6) 2010; dor: (b)(6) 2019; right hip.

Manufacturer Narrative

Product complaint #
=
> (b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot
=
> a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a4, b6, d4 (procode,lot,udi), g4, h4 and h6 (patient) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2, d3, d10, g1 and h6 (patient).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: CORAIL2 NON COL HO SIZE 12
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12309015
• MDR Text Key: 266073338
• Report Number: 1818910-2021-17619
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295258032
• UDI-Public: 10603295258032
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192946
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: L20312
• Device Catalogue Number: L20312
• Device Lot Number: 5034142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2010
• 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: 12/14 ARTICUL 40MM M SPEC+1.5; APEX HOLE ELIM POSITIVE STOP; CORAIL2 NON COL HO SIZE 12; PINNACLE 300 ACET CUP 56MM; PINNACLE MTL INS NEUT40IDX56OD; UNK HIP ACETABULAR CUP PINNACLE; UNKNOWN HIP ACETABULAR LINER; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM; UNK HIP ACETABULAR CUP PINNACLE; UNKNOWN HIP ACETABULAR LINER; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 111 KG