MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV P-F STEM TRL 12X60; STEM TRIALS

Model Number	2513-12-060
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The conexión between sleeve and stem was broken and the stem was left inside the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with the reported event was not returned for evaluation.Examination of the provided images confirmed the reported event.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 : 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = the device associated with the reported event was not returned for evaluation.Examination of the provided images confirmed the reported event.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 = 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE REV P-F STEM TRL 12X60
• Common Device Name: STEM TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10885118
• Report Number: 1818910-2020-25209
• Device Sequence Number: 19121147
• Product Code: LXH
• UDI-Device Identifier: 10603295438809
• UDI-Public: 10603295438809
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020

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
• Operator of Device: Health Professional
• Device Model Number: 2513-12-060
• Device Catalogue Number: 251312060
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 01/25/2021; 01/28/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 01/25/2021; 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1