MAUDE Adverse Event Report: LIMACORPORATE S.P.A DELTA LINERS & ACCESSORIES; NEUTRAL LIMAVIT LINER I.D. 36MM, SIZE MEDIUM+

Model Number	5885.54.259
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery of hip prosthesis was performed on (b)(6) 2026 due to unknown reason.Original surgery occurred on (b)(6) 2023 to implant the following components: - delta tt acetabular cup dia52mm (pn 5553.14.523, lot 2216711, sterilization (b)(4)) - delta neutral liner #medium (pn 5885.54.259, lot 2112535, sterilization (b)(4)) - mastersl lateralized hip stem (pn 3516.21.220, lot 2221511, sterilization (b)(4)) - biolox delta femoral head medium taper=12/14 (pn 5010.42.362, lot 2283891, sterilization (b)(4)).During revision the surgeon replaced the pre-existing liner with a new one (pn 5887.54.259).Surgery was completed as intended.The patient is female, date of birth (b)(6) 1943.The event occurred in the united states.
Additional Manufacturer Narrative
Through follow-up communication it was learned that during surgery also the original femoral stem was removed and replaced with another one from a different manufacturer, however the reason for the revision remains unknown.Review of manufacturing and sterilization records for involved batch of liner did not highlight any pre-existing anomaly or non-conformity.Complaint database review did not identify any further complaint for involved lots.Explanted components have been discarded and no x-rays to further investigate are available.Hence, taking into account that: - no anomalies were identified in dhr, - no further complaints were reported on involved lot, the manufacturer has no evidence to consider the event as product related.Based on the available pms data, the revision rate of delta liners, belonging to the family product codes 5885.54.Xxx is around (b)(4).According to the investigation carried out, no corrective action is needed for this event.The manufacturer will continue monitoring the market in order to detect any similar event.

• Brand Name: DELTA LINERS & ACCESSORIES
• Common Device Name: NEUTRAL LIMAVIT LINER I.D. 36MM, 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: 24531029
• Report Number: 3008021110-2026-00129
• Device Sequence Number: 21066269
• Product Code: LPH
• UDI-Device Identifier: 08033390136105
• UDI-Public: 8033390136105
• Combination Product (Y/N): N
• PMA/510(K) Number: K182099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 03/06/2026

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: 5885.54.259
• Device Lot Number: 2112535
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2026
• 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: 82 YR
• Patient Sex: Female