MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE; BONE SCREWS AND PINS : SCREWS

Catalog Number	121735500
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that emsys lnr aox elv 52x36, unk hip femoral head ceramic, emsys shl 3hole 52, pinn can bone screw 6.5mmx35mm, and unknown screw were involved in a reported event.The event concerned a patient who underwent a dair (debridement, antibiotics, and implant retention) procedure due to infection following implantation of an emphasys corail construct.During the operation, the cup was described as loose, but it was not removed because the patient was likely to require a multi-stage revision and screws were already in place.The reported failure included infection and implant loosening.The patient experienced harm, requiring revision of the liner and implantation of a new femoral head as part of the washout for infection.Extended hospitalization was necessary for surgical intervention to address the infection.The event is likely to result in further multi-stage revision procedures.The implant status for the liner and femoral head is explanted.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot- there is no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Added: d10 concomitant.

• Brand Name: PINNACLE
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 25045991
• Report Number: 1818910-2026-07960
• Device Sequence Number: 15932989
• Product Code: LPH
• UDI-Device Identifier: 10603295010388
• UDI-Public: (01)10603295010388(17)350331(10)D24030108
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K983014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121735500
• Device Lot Number: D24030108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EMSYS LNR AOX ELV 52X36.; UNK HIP FEMORAL HEAD CERAMIC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown