MAUDE Adverse Event Report: DePuy Orthopaedics Inc US MODULAR CATHCART BALL 47MM OD; Hemi Hip Implant : Hip Acetabular Metal Hemi

Catalog Number	136347000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the hip was dislocating over and over.Doi: (b)(6) 2026.Dor: (b)(6) 2026.Affected side: unknown.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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 synthes, or its employees that the report constitutes an admission that the product, 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.

• Brand Name: MODULAR CATHCART BALL 47MM 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 (Section G): JJMSZ Plant for Stk. & N-Stk.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50872368
• Report Number: 1818910-2026-16455
• Device Sequence Number: 10674115
• Product Code: LZY
• UDI-Device Identifier: 10603295032793
• UDI-Public: (01)10603295032793(17)350731(10)D25081615
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K903084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 136347000
• Device Lot Number: D25081615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/23/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• 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: Female