MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APEX HOLE ELIM POSITIVE STOP; PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT

Catalog Number	124603000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)
Date of Event	07/07/2025
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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported legal records were received.There is gas and soft tissue swelling surrounding the left proximal femur compatible with postoperative changes.Loosening of femoral component of prosthetic left hip, synovial fluid from hip joint, left arthritism, progressive hip pain and disability.10 ml of black stained fluid, acute metal wear process, polyethylene liner was worn through superiorly and broken in the superior rim.The ceramic ball was noted to have black staining on the superior surface, wear of articular bearing surface of internal prosthetic left hip joint, initial encounter (cms/hcc).Had severe back pain/muscle spasms.Cobalt level of 77.1 and a chromium level of 40.1.During the procedure, approximately 9 ml of yellowish fluid were removed.Moderate amount of scar tissue which was stained black consistent with a metal staining.Scar tissue was excised around the trunnion and the acetabulum circumferentially.Left hip soreness, weakness, and decreased recall of posterior.Fibrosis, focal infarction and histiocytic reaction specimen submitted as synovial scar tissue consists of an irregular rubbery segment of tan gray-red soft tissue received in formalin measuring 3.9 x 2.4 x 1.7 cm.Bisection of the specimen reveals a tan white, scar-like soft tissue.Cassette summary: a1 representative cross section leaching metals into her system.Doi: (b)(6) 2013.Dor: (b)(6) 2025.Affected area: left hip (bilateral).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.H11 additional narrative: added: h6 health effect clinical code.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.A manufacturing record evaluation was performed for the finished device d13050316 number, and no non-conformances / manufacturing irregularities were identified during manufacturing.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: a manufacturing record evaluation was performed for the finished device d13050316 number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Added: d10 concomitant.

• Brand Name: APEX HOLE ELIM POSITIVE STOP
• Common Device Name: PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT
• 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: 23692747
• Report Number: 1818910-2025-20952
• Device Sequence Number: 9211088
• Product Code: LPH
• UDI-Device Identifier: 10603295019688
• UDI-Public: (01)10603295019688(17)230430(10)D13050316
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K963309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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 Expiration Date: 04/30/2023
• Device Catalogue Number: 124603000
• Device Lot Number: D13050316
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 02/11/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/16/2025; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2013
• 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 +4 NEUT 36IDX52OD; DLT TS CER HD 12/14 36MM +8.5; PINNACLE 100 ACET CUP 52MM; SUMMIT POR TAPER SZ6 STD OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female