MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 66-70MM; PRSTHSS,HP,CNSTRND,CMNTD/UNCMNTD,MTL/POL

Model Number	71339166
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery in left thr had to be performed due to loss of acetabular fixation in screws and a zimmer cup with constrained liner.S rom stem was still in good position and well-fixed so surgeon retained s rom stem.Zimmer acetabular hardware and s rom head were removed.Another head from same length was put in.During flexion and internal rotation rom check the femoral head disassociated from constrained liner.Hip was then reduced and impacted and head kept disassociating from liner.Surgeon decided to remove liner and put a lateralized r3 68x36mm 20 degree liner.A delay of less than 30 min was reported.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to loss of acetabular fixation in screws and a zimmer cup with constrained liner.The associated device r3 liner, used in treatment, was returned and evaluated.A visual inspection of the returned device showed the liner lock ring, support ring and head were disassembled from the device.The device has signs of damage from use.The device was manufactured in 2018.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.The surgeon attempted to join the r3 constrained assembly with other competitors devices.The procedure was completed with a zimmer head, a smith and nephew liner and a depuy head.The combination of components is not recommended and issues with fit should be expected.This off-label use is the cause of this complaint.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: R3 CONST 66-70MM
• Common Device Name: PRSTHSS,HP,CNSTRND,CMNTD/UNCMNTD,MTL/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10140291
• Report Number: 1020279-2020-02306
• Device Sequence Number: 2177146
• Product Code: KWZ
• UDI-Device Identifier: 00885556021620
• UDI-Public: 00885556021620
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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 Model Number: 71339166
• Device Catalogue Number: 71339166
• Device Lot Number: 18MM08156
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 08/11/2020
• 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: Required Intervention