MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL AMT SZ13 LOW COL; FEMORAL STEMS

Model Number	L971313
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Limb Fracture (4518); Unspecified Tissue Injury (4559)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, the patient underwent the bipolar hip arthroplasty with the stem for the fracture of the femoral neck.When the surgeon checked the x-rays after insertion of all the implants, it was confirmed that the stem cut through the bone and the distal bone was cracked.Therefore, the surgeon decided to perform the osteosynthesis with anesthetized condition.The fracture site was stable with the insertion of the stem, so that the surgeon once pulled the stem proximal to the diaphysis.It was left in that state for treatment of the osteosynthesis.The osteosynthesis was performed with three nesplon cables (the other company¿s product) which were prepared for another operation and three cables (the other company¿s products).When the surgeon removed the head with the hammer, the stem and the taperloc of the head were disengaged due to vibration.The surgeon inserted the stem and the head with the hammer again and confirmed that the devices were not disengaged.The surgery was completed successfully with 100 minutes delay.According to the surgeon, the surgeon might have applied too much force externally while inserting the implants, and direction of the implant insertion may have caused this event.No further information is available.Doe: (b)(6) 2022.
Additional Manufacturer Narrative
(b)(4).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 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.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.
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
On (b)(6) 2022, it was confirmed that peri-stem fracture occurred again during a visit with a physician.According to the physician, this fracture is clearly in a different location than the previous fracture, there is likely more bone fragility than the physician expected.On (b)(6) 2022, a revision surgery will be performed with a long stem (the other company¿s implant), a plate, and cables.

• Brand Name: CORAIL AMT SZ13 LOW COL
• Common Device Name: FEMORAL STEMS
• 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: 14787265
• Report Number: 1818910-2022-11570
• Device Sequence Number: 20096397
• Product Code: LZO
• UDI-Device Identifier: 10603295478706
• UDI-Public: 10603295478706
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 06/23/2022

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
• Operator of Device: Health Professional
• Device Model Number: L971313
• Device Catalogue Number: L971313
• Device Lot Number: 9381249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 06/30/2022; 07/12/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 07/01/2022; 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2020
• 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 Age: 89 YR
• Patient Sex: Female