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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 09/21/2017

Event Type  Injury  

Event 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.

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
• Type of Device: PROSTHESIS HIP SEMI-CONSTRAINED UNCMNTD METAPOLYMERPOROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6942456
• MDR Text Key: 89163744
• Report Number: 1020279-2017-00859
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598479
• UDI-Public: 03596010598479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 71337648
• Device Lot Number: 17GM11135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability