MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM TRIAL SZ 8 RT; ATTUNE INSTRUMENTS : FEMORAL TRIALS

Model Number 2545-00-708

Device Problem Material Integrity Problem (2978)

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

Event Date 02/10/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Component code: (b)(4).Investigation summary: the device and a photo associated with this report were returned for analysis.Examination of the returned device and photo found cement residue in the femoral trial.The trial was not damaged, therefore the reported complaint was not confirmed.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that informed by cssd of damage to lug hole on femoral trial.

• Brand Name: ATTUNE CR FEM TRIAL SZ 8 RT
• Type of Device: ATTUNE INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14336251
• MDR Text Key: 291210927
• Report Number: 1818910-2022-08432
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295133803
• UDI-Public: 10603295133803
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K140881
• 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
• Report Date: 05/09/2022

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: 2545-00-708
• Device Catalogue Number: 254500708
• Device Lot Number: MVMCHH030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1