MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 60MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	71339160
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Injury (2348)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to draining postoperative hematoma.The liner and the head were removed and replaced.The patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the incomplete medical records provided, the reported elevated cocr and intraoperative findings of altr and metallosis and mild corrosion which led to a revision, may be consistent with findings associated with metal debris.However, the cause of the reported multiple recurrent dislocations cannot be concluded, as there is no supporting medical documentation provided for this time period.The patient¿s re-revision was reportedly performed as a result of persistent/perfuse hemorrhage.However, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant, as the surgeon stated that he ¿felt that the hematoma may have developed secondary to his oral anticoagulation with pradaxa versus deficient soft tissue coverage secondary to the large area of necrotic and dehisced tissue from the altr.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 the complaint history for the listed batch revealed no prior complaints for the listed failure mode with the same batch number.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.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 device or 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.We consider this investigation closed.

• Brand Name: R3 CONST 60MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10405972
• Report Number: 1020279-2020-03919
• Device Sequence Number: 14072576
• Product Code: KWZ
• UDI-Device Identifier: 00885556021330
• UDI-Public: 00885556021330
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 10/21/2024
• Device Model Number: 71339160
• Device Catalogue Number: 71339160
• Device Lot Number: 14KM13832
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71331860 , LOT: 09FM19181.; 71357008.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention