MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 16B-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number	521465
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	05/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary:fracture of s-rom hip stem at proximal sleeve area.The device associated with this report was returned to depuy synthes for evaluation.The product was returned to depuy synthes for evaluation.The depuy synthes team forwarded pictures to the depuy synthes r&d which conducted a visual inspection of the returned device.Based on review of images of the s-rom hip stem, which is comprised of a stem and proximal sleeve, the stem was fractured proximally within the sleeve.There were also cracks observed in the sleeve, through the lateral aspect of the proximal sleeve consistent with the level of fracture through the stem and at the root of the anterior proximal slot of the sleeve.The proximal sleeve exhibited bone adhesion to the porous coating, which would suggest the sleeve was likely well fixed.There was damage to the sleeve and stem consistent with damage due to the retrieval process.Beach markings characteristic of fatigue crack propagation were observed and suggested an anterolateral fatigue initiation site.Greater than 95% of the fracture surface appears to exhibit fatigue characteristics, with less than 5% due to overload.This is suggestive of low stress fatigue, as higher stresses would lead to a larger overload region.The surface of the lateral aspect of the stem proximal to the fracture surface (region previously in contact with the proximal sleeve) displayed evidence of localized wear and/or fretting.This is likely attributed to rubbing of the proximal portion of the lateral stem with the inside lateral surface of the sleeve with crack opening and closing.The cracks within the proximal sleeve were likely secondary to the stem fracture, due to the stresses generated from lateral impingement of the proximal portion of the lateral stem with crack opening against the lateral side wall of the sleeve.The proximal sleeve did appear to have been well fixed in the femur.The hip stem was cyclically loaded beyond the material limit, resulting in fatigue crack initiation and propagation.No evidence was observed to suggest material or manufacturing defects of the titanium s-rom femoral stem and sleeve.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A manufacturing record evaluation was performed for the finished device product code 521465 and lot number 3009723, and no non-conformance were identified during manufacturing.No evidence of a device nonconformance a relation of the product with the reported adverse event.As the observed condition of the 12/14srom lat 16x11x150/30+4 would contribute to the complained device issue.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 reported 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.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.
Event or Problem Description
It was reported that the sleeve is fractured.

• Common Device Name: 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: 17585553
• Report Number: 1818910-2023-17071
• Device Sequence Number: 17050558
• Product Code: LPH
• UDI-Device Identifier: 10603295170624
• UDI-Public: 10603295170624
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2014
• Device Catalogue Number: 521465
• Device Lot Number: 3009723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2009
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown