MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 58MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	71339158
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event or Problem Description
It was reported that an open reduction was performed due to dislocation.No delay or additional injuries reported.
Additional Manufacturer Narrative
The associated r3 constrained liner and cocr femoral head were not returned for evaluation.Therefore products evaluation and dimensional analysis could not be performed.However, device details were provided.Thus, a review of device history record was performed.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Our investigation indicated that the x-ray provided confirms the dislocation.However, without the request clinical information, fall history, primary operative report, open reduction procedure report, or the explant the root cause of the dislocation cannot be concluded.The further impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.Without the return of the actual products involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: R3 CONST 58MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8137538
• Report Number: 1020279-2018-02697
• Device Sequence Number: 16550569
• Product Code: KWZ
• UDI-Device Identifier: 00885556020876
• UDI-Public: 00885556020876
• Combination Product (Y/N): N
• PMA/510(K) Number: K083566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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 Expiration Date: 08/02/2026
• Device Catalogue Number: 71339158
• Device Lot Number: 16DM13899A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 05/08/2019
• 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