MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN FEM HEAD MEMPHIS OX; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number UNKNOWN

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

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 01/19/2023

Event Type  Injury  

Event Description

It was reported that, after a thr surgery, with a r3 shell, ox femoral head, and anthology ha stem, the patient had pain and a dislocation.A revision surgery had to be done on (b)(6) 2019, where the femoral head, was exchanged for another ox femoral head, and the liner was changed for a r3 xlpe liner.The stem and shell implanted during the primary surgery were not explanted.The patient's current health status is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the requested clinical documentation has not been provided.It is noted clinical/medical records are not available; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported revision cannot be determined with the information provided.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management files and prior actions review could not be performed.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient anatomy or abnormal loading of limb.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.We consider this investigation closed.

• Brand Name: UNKNOWN FEM HEAD MEMPHIS OX
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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: 16483396
• MDR Text Key: 310676137
• Report Number: 1020279-2023-00459
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093363
• 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,Followup
• Report Date: 04/03/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 03/04/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/03/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 100 KG