MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SCREW,6.5MM DIA,25MM LG; BONE SCREWS AND PINS : SCREWS

Catalog Number	556072
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Foreign Body Reaction (1868)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2008, the patient underwent a tha with the cup (non-jj product) and the screw for hip joint oa at another hospital.Following products were used for the surgery.Pinnacle-a cup (non-jj product) pinnacle metal insert 36mmid 54mmod sleeve screw 6.5x25 s-rom stem 30+4 ultamet 36mm heads +3.The surgery was completed successfully without any surgical delay.After surgery, the patient fell, and it was confirmed that the cup was loosening.At first, there was a possibility that metal-on-metal pseudotumor occurred due to trunnionosis.On (b)(6) 2024, a tha revision surgery was performed.It was confirmed that there was no metal-on-metal pseudotumor.The screw was broken.The surgeon guessed that the cup loosened due to external force from fall.The cup, liner, and stem were replaced.The s-rom sleeve was not replaced.Remarks: (b)(4) are involved with the same event.(b)(4) (non-jj product): cup.(b)(4) (synthes): screw.No further information is available.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.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 - 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.

• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20912796
• Report Number: 1818910-2024-25269
• Device Sequence Number: 7825103
• Product Code: LPH
• UDI-Device Identifier: 10603295175926
• UDI-Public: (01)10603295175926(10)286419R
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 12/12/2024

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: 07/22/2010
• Device Catalogue Number: 556072
• Device Lot Number: 286419R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2005
• 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 Sex: Unknown