MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM STD 36+12L 13X18; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 56-3618

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

Patient Problem Limb Fracture (4518)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4) - dec 14 2022.(b)(4) operative notes ad 07 dec 2022 were reviewed by clinician.On (b)(4) 2022 the patient had a right press-fit total hip arthroplasty to address primary osteoarthritis, end-stage.Depuy components were used during this procedure.The surgeon observed that there was slight crack in the calcar, so cerclage wires were placed.There was noted to be excellent stability of the stem.There is no new information provided that requires additional patient or product codes for the ips, nor does it change the existing us-fda mdr reportability determinations.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 Description

Clinical adverse event received for small calcar fx intraoperative; periprosthetic fracture.Event is serious and is considered mild.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2022.Date of event: (b)(6) 2022.(right hip).Treatment: open reduction internal fixation.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for analysis.All available x-rays were reviewed, and no evidence of implant fracture or anything indicative of a device nonconformance was found.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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.

• Brand Name: SROM STM STD 36+12L 13X18
• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15979097
• MDR Text Key: 305462081
• Report Number: 1818910-2022-25285
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295178224
• UDI-Public: 10603295178224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 56-3618
• Device Catalogue Number: 563618
• Device Lot Number: 3902216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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: ALTRX +4 NEUT 36IDX56OD; DELTA CER HEAD 11/13 36MM +6; PINNACLE SECTOR II CUP 56MM; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM STM STD 36+12L 13X18
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White