MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRL LNR NEUT 48ODX32ID; HIP INSTRUMENTS : ACETABULAR TRIALS

Model Number 2218-32-048

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2023

Event Type  Injury  

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.

Event Description

Dr.Completed a complex thr.He very rarely uses liner trials.For this case he did after implanting a 52mm gription sector cup with 3 screws (normally uses 1 or 2).The liner trial was a blue neutral 32mm / 48mm.For the femoral stem, dr.Was initially happy with broaching to the templated std 125 degree size 8 stem, which he calcarreamed and trialed with a +5 32mm head but then could not reduce it.He removed the broach and proceeded to impact the broach deeper, a size 9 broach was used, calcar ream and trial std 125 degree with +1 32mm head.This was reduced easily and a +5 32mm head was trialed with some improvement.There was then some confusion about which neck trial was used as scrub nurse said it was the dark green 135 degree short neck.Dr.Removed trial neck and confirmed std 125 degree and wanted to increase length as the patient was initially short 2cm in operative leg.The broach trial was not fully stable with rotational check, so a size 10 broach was used, calcar reamed std 135 degree neck trial and a +1 32mm head were trialed with good stability.Dr.Requested the stem and head.The 2 implants were checked by dr., assistant and scrub nurse, confirmed, opened and implanted.There was then an issue as peroxide was mistaken for local and injected into the patient.This distraction happened while scanning implant stickers.Dr.Then requested his closing sutures, 2.5mm drill and suture passer for attachments.Dr.Then closed the first several layers then unscrubbed and left the theatre and his assistant continued to close the remaining layers.I was contacted by the assistant who was writing up the medical notes (about 5 minutes after leaving the hospital) and she asked which liner we used as she could not see the implant sticker on the usage paperwork.I immediately realised the error and said dr.Needs to be contacted immediately and the trial liner will need to be removed and real liner implanted.I returned back to hospital and all theatre supervisors were aware and the patient was returning from recovery to the theatre.I discussed the issue with dr.Who stated it was a multifactorial error and he should have noticed the blue trial and brought up the point that he very rarely uses liner trials.Pt was put under ga, positioned, draped etc and dr proceeded to reopen the wound, removed the trial liner and impacted the real altrx 48mm 32mm neutral liner.Dr.Included a iodine wask and chlorohexidine wash prior to closing.

Event Description

Additional information received indicated that there was a delay of approximately 1 hour.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: PIN TRL LNR NEUT 48ODX32ID
• Type of Device: HIP INSTRUMENTS : ACETABULAR 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: 16246274
• MDR Text Key: 308168032
• Report Number: 1818910-2023-02020
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295100706
• UDI-Public: 10603295100706
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2218-32-048
• Device Catalogue Number: 221832048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female