MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 40MM COCR MODULAR HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71342640
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	06/24/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered a dislocation of the implant's femoral head.A closed reduction under anesthesia was performed on the patient to relocate the hip.No complications were reported.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and the dislocation was due to patient removal of brace and twisting leg in awkward position it is not associated with malfunction of the implant.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: 40MM COCR MODULAR HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8345795
• Report Number: 1020279-2019-00586
• Device Sequence Number: 1959083
• Product Code: MBL
• UDI-Device Identifier: 00885556022603
• UDI-Public: 00885556022603
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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: 11/17/2023
• Device Catalogue Number: 71342640
• Device Lot Number: 13KW23524
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN 71344245, BN (B)(4), TI MODHD SLEEVE 4MMXSHORT; PN 71344245, BN (B)(4), TI MODHD SLEEVE 4MMXSHORT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention