MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 14D-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number 55-0504

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)

Event Date 05/08/2023

Event Type  Injury  

Event Description

It was reported that on an unknown date, the primary surgery was performed with the implants in question.The surgery was completed successfully without any surgical delay.The revision surgery is scheduled on (b)(6) 2023, due to the suspicion of tranionosis.The detailed information will be updated at a later date.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a1, a2 (dob), a3, b5, d4 (lot), d6a, d6b, h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b3, h6 ((health effect- clinical and impact code).

Event Description

Additional information was received and stated that the revision surgery was performed on (b)(6), 2023.The surgeon left the sleeve and replaced the stem.The surgeon commented that he thought it was tranionosis with the s-rom-a stem and endurance head.The pseudotumor was a pouch of tissue on the posterior lateral side of the right hip joint, with fluid accumulation.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary; the device associated with this report was not returned to depuy synthes for evaluation.Visual inspection of the provided patient images revealed there was nothing indicative of a device non conformance.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 records evaluation (mre) was not performed.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16853792
• MDR Text Key: 314384134
• Report Number: 1818910-2023-09385
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295175209
• UDI-Public: 10603295175209
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2023

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
• Device Operator: Health Professional
• Device Model Number: 55-0504
• Device Catalogue Number: 550504
• Device Lot Number: 7862840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 05/09/2023; 07/20/2023
• Supplement Dates FDA Received: 05/11/2023; 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 9/10 COCR HEAD 28MM +0; S-ROM*SLEEVE PRX ZTT, 14D-LRG; SROM 9/10 14X9X125 30+4
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female