MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71335756
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2012 primary left hip replacement was performed and on (b)(6) 2012 patient was discharged from emergency room due to hip dislocation and a closed reduction was performed.Date of the dislocation is unknown.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that the intraoperative findings of black fluid, the reported metallosis reaction and slightly elevated cobalt levels (reported in 1020279-2018-02961) may be consistent with findings associated with metal debris, however the root cause cannot be confirmed.It cannot be concluded that the reported reactions/events were associated with a mal-performance of the implant.The root cause of the post-operative dislocation and pain cannot be determined, as complete medical records have not been provided.The patient impact beyond the revision and post-operative healing/pain cannot be determined.No further clinical assessment is warranted at this time.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of this event could include device wear or laxity in the joint.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessar.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 56MM
• 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: 9258504
• Report Number: 1020279-2019-03849
• Device Sequence Number: 19346650
• Product Code: MBL
• UDI-Device Identifier: 03596010598356
• UDI-Public: 03596010598356
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: 71335756
• Device Catalogue Number: 71335756
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 02/26/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 57 YR