MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 UNK HIP FEMORAL STEM CORAIL

Catalog Number UNK HIP FEMORAL STEM CORAIL

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

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888)

Event Date 01/04/2010

Event Type  Injury  

Event Description

Pc was created to capture the event.On (b)(6) 2010, the patient had a right total hip arthroplasty to address right hip arthritis.Depuy components were used during this procedure, including a ceramic head.Post-surgery, anemia secondary to blood loss was noted.The patient was transfused with 250 cc of cell saver blood intraoperatively and on postoperative day #2, due to low hematocrit and hemoglobin the patient was transfused with 1 unit of autologous blood.Doe: (b)(6) 2010 right hip.Please see (b)(4) right hip (1st revision).(b)(4) left hip (1st revision).

Manufacturer Narrative

Product complaint # (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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.There is no specified allegation associated with this product.The symptoms experienced are likely procedure related, not product.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 : there is no allegation associated with this product.A complaint database search and/or device manufacturing (mre) review will not be performed even when lot information is known.

• Brand Name: UNK HIP FEMORAL STEM CORAIL
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex 69801 ; FR 69801
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13290727
• MDR Text Key: 288686907
• Report Number: 1818910-2022-01192
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM CORAIL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 01/19/2022
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 03/08/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female