MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCORD LG 30 DEG CBL OFF PSR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71360019
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that the accord lg 30 degrees cbl off psr was found cracked.No procedure-related.Therefore, no injuries or surgical delays were reported.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So, the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.

• Brand Name: ACCORD LG 30 DEG CBL OFF PSR
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10928825
• Report Number: 1020279-2020-06877
• Device Sequence Number: 2322358
• Product Code: JDG
• UDI-Device Identifier: 03596010500236
• UDI-Public: 03596010500236
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71360019
• Device Catalogue Number: 71360019
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1