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

Catalog Number	71338663
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered an acetabular shell dislocation.The event was resolved with revision surgery.Cup has been destroyed and is not available for investigation.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A review of complaint history's revealed no prior complaints for the listed lots.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 reported the removed components were destroyed.Several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.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 MULTI HOLE ACETABULAR 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: 7663695
• Report Number: 1020279-2018-01265
• Device Sequence Number: 2355222
• Product Code: MBL
• UDI-Device Identifier: 00885556021941
• UDI-Public: 00885556021941
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2018

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 Catalogue Number: 71338663
• Device Lot Number: 17BM13252
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 09/08/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 46