MAUDE Adverse Event Report: LIMACORPORATE S.P.A DELTA LINERS & ACCESSORIES; NEUTRAL LIMAVIT LINER I.D. 32MM, SIZE MEDIUM-

Model Number	5885.54.157
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026.Patient was dislocating the hip anterior.Previous surgery occurred on (b)(6) 2026, when delta tt pro acetabular cup dia48mm (pn 5553.14.482, lot 2202752, sterilizaztion 2200083) and delta neutral liner medium (pn 5885.54.157, lot 25at28x, sterilization 2500129) were implanted in combination with unknown fmeoral components.Since patient was dislocating the hip, the above mentioned acetabular cup and liner were removed and replaced with an acetabular assembly consisting of: delta tt acetabular cup dia50mm (pn 5552.15.500), delta dual mobility liner medion for mobile liner dia40 (pn 5885.09.040), delta mobile liner (pn 5566.50.401).Surgery was completed as intended.Patient is female, date of birth (b)(6) 1947.The event occurred in the united states.
Additional Manufacturer Narrative
Preliminary review of manufacturing records did not highlight any pre-existing anomaly or non-conformity that could have contributed to reported issue.The manufacturer will submit a final report as soon as the investigation is completed.

• Brand Name: DELTA LINERS & ACCESSORIES
• Common Device Name: NEUTRAL LIMAVIT LINER I.D. 32MM, SIZE MEDIUM-
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 25278191
• Report Number: 3008021110-2026-00221
• Device Sequence Number: 13276983
• Product Code: LPH
• UDI-Device Identifier: 08033390136099
• UDI-Public: 8033390136099
• Combination Product (Y/N): N
• PMA/510(K) Number: K182099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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: 5885.54.157
• Device Lot Number: 25AT28X
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2026
• 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 Age: 79 YR
• Patient Sex: Female