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

Model Number	FEMORAL HEAD
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The check of the device history records of involved lot numbers, confirmed the absence of pre-existing anomalies on the components manufactured with those lot numbers.No other previous complaint registered on these lot numbers.We will submit a final report after the conclusion of the investigation.
Event or Problem Description
Hip prothesis revision surgery performed on (b)(6), 2023.The femoral modular head - s ø28mm (product code 5010.09.281, lot nr.1505799) was not able to rotate inside the mobile liner øint 28 mm ø42 mm (product code 5566.50.420, lot nr.15at0ll - ster.1500213).This caused recidieve bruising and a decrease of range of motion.Patient is a female, age 67.The following components got explanted: - femoral modular head - s ø28mm (product code 5010.09.281, lot #1505799).- delta-one-tt acetab.Cup ø56mm (product code 5549.14.560, lot #1505095 - ster.1500151) - product not sold in the us.- mobile liner øint 28 mm ø42 mm (product code 5566.50.420, lot #15at0ll - ster.1500213).
Additional Manufacturer Narrative
The check of the device history records of involved lot numbers, confirmed the absence of pre-existing anomalies on the components manufactured with those lot numbers.According to our data at least (b)(4) pieces manufactured with lot 15at0ll - ster.(b)(4), have been implanted.This is the first and only complaint received on this lot number.According to our data at least (b)(4) pieces manufactured with lot 1505799 - ster.(b)(4), have been implanted.This is the first and only complaint received on this lot number.According to our data at least (b)(4) pieces manufactured with lot 1505095 - ster.(b)(4), have been implanted.This is the first and only complaint received on this lot number.According to our data at least (b)(4) pieces manufactured with lot:1505775 - ster.(b)(4), have been implanted.This is the first and only complaint received on this lot number.The explants of fem.Modular head - s ø28mm, mobile liner øint 28 mm ø42 mm and liner #l for mobile liner ø42 were returned to lima corporate for further investigation.Fem.Modular head and mobile liner øint were received assembled together.During our analysis it was confirmed that the femoral modular head does not rotate well inside the mobile liner.To proceed with a deeper investigation, a destructive analysis would be necessary.Unfortunately, we did not receive a response to our request for customer approval to proceed with this, despite several attempts.Therefore, a deeper investigation, to understand if the fem.Modular head was correctly pressed/assembled in the mobile liner, was not possible to be performed.Even though requested, x-rays (pre-op and post-op) were not provided by the complaint source.Based on the information available and considering the impossibility to performed deeper investigation on the explants, we cannot determine with certainty the root cause of the event.The check of the device history records confirmed the absence of pre-existing anomalies on the lot numbers involved, therefore we classify this event as not product related.Pms data: according to limacorporate pms data, revision rate due to loss of mobility between femoral heads and mobile liners, is about (b)(4).Being the reported issue related to a combination of two devices, for the calculation of revision rate, it was considered the number of similar complaints reported (limacorporate femoral heads do not rotate into the mobile liners) and the total number of mobile liner sold ww.This is an mdr final report.
Event or Problem Description
Hip revision surgery of delta one prothesis performed on (b)(6) 2023.The fem.Modular head - s ø28mm (product code 5010.09.281, lot #1505799) was not able to rotate inside the mobile liner øint 28 mm ø42 mm (product code 5566.50.420, lot #15at0ll - ster.(b)(4)).This caused recidieve bruising and a decrease of range of motion.The surgeon informed that there was recurrent seroma formation with pain in the hip.During revision surgery the surgeon decided to insert a polyethylene and use a 36 head.After revision the patient was doing very well and no longer has the preoperative symptoms and no more seroma formation.Previous surgery performed on (b)(6) 2015.Patient is a female, age 67, height 162cm, no relevant clinical disease, no traumatic event, activity level: walking and fitness, occupation: retired.The following components got explanted: - fem.Modular head - s ø28mm (product code 5010.09.281, lot #1505799 - ster.(b)(6)) - mobile liner øint 28 mm ø42 mm (product code 5566.50.420, lot #15at0ll - ster.(b)(6)) - liner #l for mobile liner ø42 (product code: 5885.09.042, lot:1505775 - ster.(b)(6)) - device returned from complaint source and was not initially reported.Delta-one-tt acetab.Cup ø56mm (product code 5549.14.560, lot #1505095 - ster.(b)(6)), was not changed during revision surgery.Event occurred in switzerland.

• Brand Name: COCRMO
• Common Device Name: MODULAR FEMORAL HEADS (COCRMO) DIA. 28MM S TAPER 12/14
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18158040
• Report Number: 3008021110-2023-00133
• Device Sequence Number: 7982334
• Product Code: LPH
• UDI-Device Identifier: 08033390006781
• UDI-Public: 08033390006781
• Combination Product (Y/N): N
• PMA/510(K) Number: K112158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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: FEMORAL HEAD
• Device Catalogue Number: 5010.09.281
• Device Lot Number: 1505799
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 10/04/2024
• 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: Female