MAUDE Adverse Event Report: LimaCorporate S.p.A Lock Bipolar Femoral Head; Lock Bipolar Femoral Head - Dia.49mm for Heads Dia.28mm

Model Number	5527.09.490
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision was performed due to dissociation of c-ring for the bipolar cup on (b)(6) 2026.The primary surgery was performed in 2017.The timing of the dissociation was unknown, but the c-ring had disengaged and was found caught around the stem neck.The split portion of the c-ring appeared to be slightly widened and deformed.No significant wear or damage was identified.Furthermore, no remarkable scratches or other abnormalities were observed on the metal liner of the cup or on the surface of the cocr head.There was also no evidence of metallosis, such as pigment deposition within the joint.After confirming adequate range of motion and suction fit using a trial bipolar cup of the same size, reimplantation was performed using a new bipolar cup of the same size and a revision head of the same size (28 mm, medium).Although the preoperative and postoperative radiographs from this revision procedure showed no apparent joint space on the affected side, intraoperative assessment with the trial components demonstrated sufficiently smooth mobility and satisfactory suction stability.Product explated: fem.Modular head - m ø28mm (code 5010.09.282, lot unknown).Lock bipol.Self-cent.Head ø49(code 5527.09.490, lot unknown).Patient is female, 75 years old.Event happened in japan.
Additional Manufacturer Narrative
Investigation check of the dhr are not yet available because lots information is missing.We will submit the final mdr upon the completion of the investigation.

• Brand Name: Lock Bipolar Femoral Head
• Common Device Name: Lock Bipolar Femoral Head - Dia.49mm for Heads Dia.28mm
• Manufacturer (Section D): LimaCorporate S.p.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 50803164
• Report Number: 3008021110-2026-00373
• Device Sequence Number: 18306098
• Product Code: LPH
• UDI-Device Identifier: 08033390297899
• UDI-Public: 08033390297899
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K112158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• 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?: No
• Device Model Number: 5527.09.490
• Device Catalogue Number: 5527.09.490
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown