MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR CATHCART BALL 48MM OD; HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI

Model Number 1363-48-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 12/28/2021

Event Type  Injury  

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

The patient was revised due to medial acetabulum pain.Doi: (b)(6) 2017.Dor: (b)(6) 2021.(unknown side).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: MODULAR CATHCART BALL 48MM OD
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI
• 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: 13250633
• MDR Text Key: 283754988
• Report Number: 1818910-2022-00716
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 10603295032809
• UDI-Public: 10603295032809
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1363-48-000
• Device Catalogue Number: 136348000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MODULAR CATHCART BALL 48MM OD; TAPERED SPACER ARTICUL/EZE +5
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 55 KG