MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE CONV FB PS TB TRL SZ7; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number	2545-00-977
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an email from surgeon was received: i am writing to inform you of an incident that occurred intra-operatively but became apparent to me today.Essentially, it is that of a retained piece of metal following a knee replacement i did on friday.I was telephoned by dr (radiologist) this afternoon to inform me of an odd looking radiolucent material just behind the tibial insert.When i reviewed the post-operative x-rays on saturday, i had thought this was a bit of cement so did not think much of it.Dr was able to send me high quality magnified images which suggested otherwise.It is probably a balseal (wire spring) that has come off the tibial insert trial (please see picture i have attached below).The procedure went smoothly and patient went home on sunday.As part of my duty of candour, i telephoned my patient this afternoon and explained the findings to her.I have also apologised to her for this.She is doing well and i have suggested that i intend to leave it in situ as it is small and unlikely to cause any major issues.I have also discussed this with my colleague who feel this is reasonable.I will also be seeking other opinion.I plan to have a face to face meeting with my patient so i can show her the x-rays and go through once more and ensure she is happy with the plan of leaving it.I do not think this will have any adverse effect on her.I feel it would be important that due process is followed and that you carry out any theatre investigations as necessary.I suspect you will want to identify the set used and confirm one of the balseal¿s is missing from one of the inserts.I used a size 7 femur and tibia so you may want to start by looking at the 7 inserts of differing thicknesses.I can only imagine it dislodged in my final trial once the cement went off and before i inserted the real insert.There were no issues with the final count but a small spring that has dislodged from an insert trial is not going to be picked up from a count as the insert would have been what was counted.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.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).A manufacturing records evaluation (mre) was not performed.
Event or Problem Description
Additional information received indicated that the articulating surface was missing the spring/seal.There was no delay.
Additional 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 which has not been investigated or verified 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.Detachment of device or device component (a0501) is used to capture functional: fell apart - unattached and visual: missing components.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE CONV FB PS TB TRL SZ7
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15713786
• Report Number: 1818910-2022-21835
• Device Sequence Number: 11986182
• Product Code: HWT
• UDI-Device Identifier: 10603295135548
• UDI-Public: 10603295135548
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2022

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
• Operator of Device: Health Professional
• Device Model Number: 2545-00-977
• Device Catalogue Number: 254500977
• Device Lot Number: BFA0MA3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 11/02/2022; 11/21/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 11/04/2022; 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2142-2015
• Patient Sequence Number: 1
• Patient Sex: Unknown