MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BIOLOX DELTA; PROSTHESIS, HIP

Catalog Number	136536210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
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.H11 additional narrative: d2a: prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented.
Event or Problem Description
It was reported that items were explanted due to infection.Affected side: unknown hip.
Additional Manufacturer Narrative
Product complaint # = >(b)(4).Investigation summary = > according to the information received, it was reported that items were explanted due to infection.The product was not returned to depuy synthes; however, photos were provided for review.See attachment (b)(4) sticker sheet 22 may 2026.The photographs attached were reviewed, however they do not represent the reported delta cer head 11/13 36mm +0.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the photographs provided are not representative of the reported delta cer head 11/13 36mm +0.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = > 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 manufacturing records evaluation (mre) was not performed.Added : d10 concomitantl.

• Brand Name: BIOLOX DELTA
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 25457591
• Report Number: 1818910-2026-09982
• Device Sequence Number: 15630427
• Product Code: MRA
• UDI-Device Identifier: 10603295033561
• UDI-Public: (01)10603295033561(17)280229(10)4113203
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K011533
• 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: 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 136536210
• Device Lot Number: 4113203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/18/2026
• Supplement Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2023
• 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: ALTRX NEUT 36IDX56OD; PINN CAN BONE SCREW 6.5MMX35MM; PINN SECTOR W/GRIPTION 56MM; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM*STM ST,36+8L NK,18X13X160
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown