MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 48MM; PROSTHESIS HIP SEMI-CONSTRAINED UNCMNTD METAPOLYMERPOROUS

Catalog Number	71337648
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the doctor revised the acetabular shell on the patient.It was removed the liner, hole cover, shell and femoral head.The patient had poor bone stock and the cup shifted.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A clinical investigation concluded that this complaint reports a revision approximately sixteen days post implantation due to loosening.There are no supporting clinical documents available.However, it was reported that the patient had poor bone stock and the cup shifted.The patient impact beyond the revision surgery is unknown, as there is no report of the patient¿s current condition or how the procedure was tolerated.A lab analysis revealed scratches and damage on the returned oxinium femoral head and the returned r3 liner.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal any material or manufacturing deviations that could have caused or contributed to the reported incident.Based on the lack of information, the exact root cause for the loosening cannot be determined.A thorough clinical assessment cannot be performed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 48MM
• Common Device Name: PROSTHESIS HIP SEMI-CONSTRAINED UNCMNTD METAPOLYMERPOROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6942456
• Report Number: 1020279-2017-00859
• Device Sequence Number: 566942
• Product Code: MBL
• UDI-Device Identifier: 03596010598479
• UDI-Public: 03596010598479
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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: Lay User/Patient
• Device Catalogue Number: 71337648
• Device Lot Number: 17GM11135
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 04/25/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability