MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTIC/EZE TR BALL GRVD 32+5; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number 2530-92-000

Device Problems Device-Device Incompatibility (2919); Unintended Movement (3026)

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

Event Date 02/01/2022

Event Type  malfunction  

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 Description

It was reported that during the surgical procedure, at the time of carrying out the reduction with the rasp, neck and trial head, it is observed that it is the indicated stem, therefore, the definitive one is requested.However, the head is a bit short and therefore the specialist decides to place a definitive stem and perform the test with a neutral head.At the moment of carrying out the maneuver to reduce, it is observed that it loosens and remains in the cavity, at the moment of being requested to the specialist, he comments that he does not observe it in the field, therefore, he inserts his fingers to see if he touches it and it is indeed there, however, for several minutes he tries to remove it, but it lodges in a space that is in the anterior part and migrates towards the abdominal cavity.The specialist decides to carry out the test with the next head, since he had managed to observe a fairly high pistoning.However, for this it is suggested to place a suture thread to be able to remove it without problems and he accepts, performs the reduction and when he begins to do the flexion, extension and rotation tests, and the same thing happens again, the hip becomes to dislocate and the head comes loose, but this time due to the suture it was easier to remove it.The assistant who accompanies the main specialist tells him that the stem is very anteverse and that perhaps that is why the hip dislocated anteriorly and the head came out, to which he asked me what the position looks like and he was confirmed that it looks very anterior, therefore it is decided to correct the position of the definitive stem and perform tests again, and it is observed that the same does not happen anymore, but rather a good reduction and good arch tests are achieved.Therefore, a definitive head is requested, it is implanted without incident and corresponds to what the patient requires.In addition, an additional approach is needed at the end of the procedure to be able to extract the trial head.

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.

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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

Event Description

Additional information was received stating that the surgery was extended in surgical time by about an hour.In addition, the patient had to perform an additional approach in the abdominal cavity in order to be able to remove the parts mentioned.

• Brand Name: ARTIC/EZE TR BALL GRVD 32+5
• Type of Device: HIP INSTRUMENTS : FEMORAL 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13522587
• MDR Text Key: 288585334
• Report Number: 1818910-2022-02772
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295129004
• UDI-Public: 10603295129004
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup,Followup
• Report Date: 02/14/2022

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: 2530-92-000
• Device Catalogue Number: 253092000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 02/15/2022; 02/28/2022; 03/16/2022
• Supplement Dates FDA Received: 02/23/2022; 03/14/2022; 03/18/2022
• 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