MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71339556
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2011
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient suffered a dislocation three weeks after his right total hip replacement.There is not any notification that a medical intervention or treatment was performed to correct the problem.
Additional Manufacturer Narrative
The associated complaint devices were not returned.Without the actual product involved, our investigation cannot proceed.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.The clinical/medical team also concluded that without the supporting clinically relevant documents, a thorough clinical investigation cannot be rendered.If the devices or new information is received in the future, these complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: R3 0 DEG XLPE ACET LNR 32MM X 56MM
• 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: 7816115
• Report Number: 1020279-2018-01631
• Device Sequence Number: 1517894
• Product Code: MBL
• UDI-Device Identifier: 03596010615251
• UDI-Public: 03596010615251
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2018
• Device Catalogue Number: 71339556
• Device Lot Number: 08GM11827
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 12/19/2018
• 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
• Patient Weight: 86