MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 11 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92511

Device Problem Loss of Osseointegration (2408)

Patient Problems Muscular Rigidity (1968); Pain (1994); Renal Failure (2041); Weakness (2145); Anxiety (2328); Discomfort (2330); Depression (2361); Osteolysis (2377); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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 litigation and medical records received. Litigation alleges pain, discomfort, weakness, limited adl, stress, anxiety, depression, insomia and ckd stage 3. After review of medical records the patient was revised to address pain and osteolysis. Mri confirm presence of ostial lysis around femur but no loosening. Clinical visit reported tenderness over greater trochanter, discomfort, instability, stiffness, difficulty adl, metalic streak artifact obscure the tendons, some cortical hypertrophy at the tip of the stem but no loosening. Doi: (b)(6) 2007; dor: (b)(6) 2018; right hip.

• Brand Name: CORAIL2 STD SIZE 11
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8DT; EI LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10143911
• MDR Text Key: 194825064
• Report Number: 1818910-2020-13649
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 3L92511
• Device Catalogue Number: 3L92511
• Device Lot Number: 2262937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/11/2020 Patient Sequence Number: 1

Treatment

ARTICULEZE M HEAD 36MM -2; CORAIL2 STD SIZE 11; PINNACLE 100 ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD