MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71335550
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a cup dislocation which needed to be revised.
Additional Manufacturer Narrative
The affected r3 3 hole acetabular shell 50mm was not returned for evaluation.A clinical evaluation noted several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation can be performed.Should information become available this complaint can be re-assessed.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation of this report is inconclusive.Should the device or additional information be received in the future, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 3 HOLE ACET SHELL 50MM
• 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: 7489529
• Report Number: 1020279-2018-00873
• Device Sequence Number: 10803162
• Product Code: MBL
• UDI-Device Identifier: 03596010598233
• UDI-Public: 03596010598233
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

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: 71335550
• Device Lot Number: 17GW14406
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/06/2018
• Supplement Report FDA Received Date: 06/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention