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
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	12/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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 on an unknown date, the patient underwent the surgery via tha for right oa with s-rom-a stem in question.The surgery was completed successfully without any surgical delay.After the surgery, it was confirmed on (b)(6) 2022, that the stem broke on body part and slit root part.It can see the broken parts in the attached photo.A revision surgery is planned on (b)(6) 2023.The surgeon wants to know the occurrence situation of the event where the stem is broken in two places (stem body part and slit base part) like this time.No further information is available.
Additional 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:  if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received indicated that the patient had not received follow-up visits after the operation, and the timing of the stem breakage was unknown.It was found that it was broken when it was examined due to the inability to walk on (b)(6) 2022.In the revision surgery, the stem and the sleeve were removed under eto.The broken piece of the stem distal was removed by incision of the femoral shaft.The stem in question was replaced competitor's product (lima).The liner on the cup (competitor's product: zb) was replaced also.Doi: (b)(6) 2013.Dor: (b)(6) 2023.
Additional 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the device and the provided photo evidence cannot confirmed, the reported allegation.No fractures were found on the implant.No defects that could contributed to the reported event were observed.Additional monitoring, for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device product code: 550504 and lot number#: 3412457.And no non-conformance / irregularities related to the malfunction were identified, during manufacturing.Device history review : a manufacturing record evaluation was performed for the finished device product code: 550504 and lot number#: 3412457.And no non-conformance / irregularities related to the malfunction were identified, during manufacturing.

• 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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16137617
• Report Number: 1818910-2023-01000
• Device Sequence Number: 6610266
• Product Code: LPH
• UDI-Device Identifier: 10603295175209
• UDI-Public: 10603295175209
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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,Followup,Followup,Followup
• Report Date (Section B): 01/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 55-0504
• Device Catalogue Number: 550504
• Device Lot Number: 3412457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 01/13/2023; 02/16/2023; 03/17/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 01/23/2023; 02/20/2023; 03/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2012
• 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: 9/10 COCR HEAD 28MM -3; S-ROM*SLEEVE PRX ZTT, 14D-LRG; SROM 9/10 14X9X125 30+4; SROM 9/10 14X9X125 30+4
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 53 KG