MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 11; HIP FEMORAL STEM

Model Number L20311

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2021

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

Fitting issue with the broach and implant.Original implant could not be used; surgeon used corail cemented implant instead.Surgical delay of 15-20 occurred.

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 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: the device was received for investigation.The photo investigation can confirm the reported allegation, but no definitive root cause can be established.Investigation of the returned device found the dimensions to be under the tolerance range.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a search of the depuy nonconformance (nc) quality system could not be performed with the provided information, a finished goods lot number was not provided.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: the device was received for investigation.The photo investigation can confirm the reported allegation, but no definitive root cause can be established.Investigation of the returned device found the dimensions to be within the tolerance range.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a search of the depuy nonconformance (nc) quality system could not be performed with the provided information, a finished goods lot number was not provided.

Event Description

Affected side: right side.

• Brand Name: CORAIL2 NON COL HO SIZE 11
• Type of Device: 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): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex IN 69801 ; FR 69801
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13093102
• MDR Text Key: 282819535
• Report Number: 1818910-2021-28806
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295258025
• UDI-Public: 10603295258025
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L20311
• Device Catalogue Number: L20311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 01/06/2022; 03/11/2022; 03/14/2022
• Supplement Dates FDA Received: 01/13/2022; 03/12/2022; 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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