MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71331848
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a surgical intervention was performed due to dislocation, all parts were removed.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.A review of complaint history revealed no prior complaints for the listed lot.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Our clinical/medical investigation concluded: no clinically supporting documentation has been provided for inclusion in this investigation.Without the explant, or the requested clinical information the root cause of the dislocation cannot be determined.The impact to the patient beyond the dislocations cannot be concluded.No further clinical/medical assessment is warranted at this time.Without the actual product involved, 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.We consider this investigation closed.

• Brand Name: R3 0 HOLE ACET SHELL 48MM
• 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: 7140022
• Report Number: 1020279-2017-01326
• Device Sequence Number: 16446779
• Product Code: MBL
• UDI-Device Identifier: 03596010597571
• UDI-Public: 03596010597571
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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: 05/01/2020
• Device Catalogue Number: 71331848
• Device Lot Number: 10EM01302
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention