MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ7 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157011135
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Fatigue (1849); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Depression (2361); Cramp(s) /Muscle Spasm(s) (4521); Metal Related Pathology (4530); Bone Notching (4890)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2010, patient underwent a right total hip replacement.On (b)(6) 2023, patient underwent aspiration right hip due to right painful total hip arthroplasty.On (b)(6) 2023, the patient underwent a right total hip arthroplasty due to adverse metal reaction and elevated cobalt levels.The patient had increase fatigue and depression then developed tremors and eventually more pain.During operations, rusty colored fluid upon incision into the capsule along with necrotic rusty-stained tissue on the inside of the capsule were found.Furthermore, a fair amount of bone loss was noted and bone was extremely thin and ridge could be palpated.It was also observed that there was corrosion occurring at the taper junction in the femoral neck.Doi: (b)(6) 2010, dor: (b)(6) 2023, affected site: right hip.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product code: 157011135 lot number: ee5f91 manufacturing date: 10-feb-2010 expiry date: 08-feb-2020 quantity manufactured: (b)(4).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 product code: 157011135 lot number: ee5f91 manufacturing date: 10-feb-2010 expiry date: 08-feb-2020 quantity manufactured: (b)(4).Device history review a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: added: b1 (is product problem) and d10.

• Brand Name: SUMMIT POR TAPER SZ7 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• 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: 22916053
• Report Number: 1818910-2025-14922
• Device Sequence Number: 9755523
• Product Code: LPH
• UDI-Device Identifier: 10603295060086
• UDI-Public: (01)10603295060086(17)200208(10)EE5F91
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• 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 Expiration Date: 02/08/2020
• Device Catalogue Number: 157011135
• Device Lot Number: EE5F91
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2010
• 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: 12/14 ARTICUL 40MM M SPEC-2; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MTL INS NEUT40IDX56OD; PINNACLE SECTOR II CUP 56MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Unknown