MAUDE Adverse Event Report: LIMACORPORATE S.P.A. COCRMO; MODULAR FEMORAL HEADS (COCRMO) DIA. 28MM L TAPER 12/14

Model Number	5010.09.283
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No pre-existing anomaly was detected by the check of the sterilization charts of the lot numbers involved.No other complaint due to infection was recorded on the ster.Numbers involved.A final report will be submitted after the conclusion of the investigation.
Event or Problem Description
Patient had prosthesis infection that required revision of the implant.The following components were explanted: lock bipol.Self-cent.Head ø51 code 552709510, lot 2106980 ster.(b)(4), fem.Modular head - l ø28mm code 501009283, lot 2303790 ster.(b)(4), h-max c standard fem.Stem #10 code 426007100, lot 2226621ster.(b)(4).During the revision a spacer was implanted.The revision surgery took place on (b)(6) 2023, the previous surgery was performed on (b)(6) 2023.Patient is male, 69 years old.Event occurred in slovenia.

• Brand Name: COCRMO
• Common Device Name: MODULAR FEMORAL HEADS (COCRMO) DIA. 28MM L TAPER 12/14
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24995511
• Report Number: 3008021110-2026-00191
• Device Sequence Number: 9033988
• Product Code: KWZ
• UDI-Device Identifier: 08033390006804
• UDI-Public: 8033390006804
• Combination Product (Y/N): N
• PMA/510(K) Number: K112158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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 Model Number: 5010.09.283
• Device Lot Number: 2303790
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/27/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown