MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ZIRC 12/14 FEM HD 28 + 0; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	71320028
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/22/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Us legal: it was reported that a revision surgery was performed due to recurrent dislocations and instability.Liner and head were removed.This patient underwent a closed reduction on (b)(6) 2011 and a dislocation on (b)(6) 2013.In addition to this the patient had a fall in (b)(6) 2013 and presented trochanteric bursitis due to this incident.
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 patient¿s recurrent dislocations and rt tha 1st revision were reported as due to the patient¿s ¿soft tissue incompetence¿, and possibly the asymmetric positioning and size of the acetabular cup.The report of metallosis of the trunnion may be consistent with findings associated with metal debris, which may be a result of the reported ¿damage on the trunnion¿ but it cannot be conclude if this damage was a result of the multiple dislocations, previous revisions, or something else.This cannot be confirmed without supporting lab reports, imaging, and/or the analysis of the explanted components, and it cannot be concluded that the recurrent dislocations and clinical reaction were associated with a mal-performance of the implant.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 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.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 the reported event could include improper device positioning or sizing.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the devices or additional information be received, the complaints will be reopened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: ZIRC 12/14 FEM HD 28 + 0
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9253271
• Report Number: 1020279-2019-03794
• Device Sequence Number: 19340613
• Product Code: LZO
• UDI-Device Identifier: 03596010196187
• UDI-Public: 03596010196187
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K971414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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: 71320028
• Device Catalogue Number: 71320028
• Device Lot Number: 02EM00803A
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 02/07/2020
• 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