MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S/C & MOD CATH TRL 47/28; HIP INSTRUMENTS : ACETABULAR TRIALS

Model Number 2055-47-000

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 04/02/2021

Event Type  malfunction  

Manufacturer Narrative

(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

During the procedure, the bipolar cup test remained inside the patient and it became difficult to extract it.The specialist decided to extract it with a forceps causing damage to the cup.

Manufacturer Narrative

Product complaint #
=
>(b)(4) investigation summary
=
> the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.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.Device history review
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> a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: S/C & MOD CATH TRL 47/28
• Type of Device: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11732978
• MDR Text Key: 247544354
• Report Number: 1818910-2021-08216
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295084648
• UDI-Public: 10603295084648
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

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
• Device Operator: Health Professional
• Device Model Number: 2055-47-000
• Device Catalogue Number: 205547000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1