MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 26 + 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 71302600

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Joint Dislocation (2374)

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after thr surgery had been performed on (b)(6) 2020, the patient fell and suffered from dislocation.This adverse event was addressed by revision surgery on (b)(6) 2024, in which when trying manual reduction, it was found the cocr head was disassociated from tandem bipolar.Therefore, the cocr 12/14 fem head 26 + 0, tndm bp shl/xlpe lnr 40od 26id and sl-plus integr mia stem with ti/ha 2 were exchange.Patient's current health status is unknown.

• Brand Name: COCR 12/14 FEM HEAD 26 + 0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 18608931
• MDR Text Key: 334115897
• Report Number: 1020279-2024-00253
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 03596010194077
• UDI-Public: 03596010194077
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K963509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 71302600
• Device Lot Number: 20FM06297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 01/30/2024
• Date Device Manufactured: 06/09/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PN: 71325040, LOT: 14HM20538; PN: 75000175, LOT: UNKNOWN
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female