MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS COCR PRIM HO 12/14 SZ 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71312374
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	09/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that, after thr surgery performed on (b)(6) 2021, patient suffered a fall resulting in a periprosthetic fracture.This adverse event was solved by a revision surgery on (b)(6) 2021, in which the oxinium fem hd 12/14 36 mm +0, cpcs cocr prim ho 12/14 sz 4 and cpcs dist cent sz 14mm were revised.Current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the periprosthetic fracture was confirmed.The clinical/medical investigation concluded that, reportedly, the root cause of the revision was the ¿fall resulting in a periprosthetic fracture¿.The assessed patient impact was the reported fall, fracture and revision/reduction procedure.Further patient impact could not be determined.The current patient status remains unknown.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant and traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: CPCS COCR PRIM HO 12/14 SZ 4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12560989
• Report Number: 1020279-2021-07371
• Device Sequence Number: 1546809
• Product Code: JDI
• UDI-Device Identifier: 03596010462176
• UDI-Public: 03596010462176
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K823727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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 Expiration Date: 10/09/2025
• Device Model Number: 71312374
• Device Catalogue Number: 71312374
• Device Lot Number: 15KM07578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2015
• 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: Hospitalization; Other
• Patient Age: 61 YR
• Patient Sex: Unknown