MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM M/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71343604
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a bilateral tha performed on (b)(6) 2021, the patient suffered from a dislocation on (b)(6) 2021.Manual repositioning was performed.The causal relationship and severity have not been determined as of today.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, approximately 1& ½ weeks post bilateral tha, the patient dislocated the left hip for which a closed reduction was performed.The event was considered resolved.This event (ae01 for subject 12.012 participating in polar3.Hip.Pro.2019.02 study) was preliminary classified as sade (serious adverse device effect); however, after further response from the investigational site, the event was considered unrelated to the study device ¿¿because the dislocation was caused by a fall¿ evidenced by the crf documentation.Based on this information, the aemb found the event to represent a sae (serious adverse event) unrelated to the use of study device, and do not anymore believe that the event represents a complaint allegation per pol-qa-010.¿ based on this information, no further medical assessment is warranted.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.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.
Additional Manufacturer Narrative
This report was inadvertently submitted under manufacturer number (b)(4), the correct manufacturer number is (b)(4).

• Brand Name: OXINIUM FEM HD 12/14 36 MM M/+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: 11593542
• Report Number: 9613369-2021-00131
• Device Sequence Number: 14306538
• Product Code: JDI
• UDI-Device Identifier: 03596010477286
• UDI-Public: 03596010477286
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2022

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: 71343604
• Device Catalogue Number: 71343604
• Device Lot Number: 19LM08307
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 07/22/2021; 04/26/2022
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 07/27/2021; 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Required Intervention; Other
• Patient Sex: Male
• Patient Weight: 78 KG