MAUDE Adverse Event Report: DePuy Orthopaedics Inc US MODULAR CATHCART BALL 46MM OD; Hemi Hip Implant : Hip Acetabular Metal Hemi

Catalog Number	136346000
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury

• Brand Name: MODULAR CATHCART BALL 46MM OD
• Common Device Name: Hemi Hip Implant : Hip Acetabular Metal Hemi
• Manufacturer (Section D): DePuy Orthopaedics Inc US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50156424
• Report Number: 1818910-2026-13449
• Device Sequence Number: 21167423
• Product Code: LZY
• UDI-Device Identifier: 10603295032786
• UDI-Public: (01)10603295032786(17)221105(10)D17101936
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K903084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2022
• Device Catalogue Number: 136346000
• Device Lot Number: D17101936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1818910-05/18/2022-002-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown