MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN FEMORAL STEM IMPLANT; PRSTHSS,HP,SM-CONSTRAINED,MTL/CERAMIC/CERAMIC/MTL,CMNTD OR UNCE

Model Number	71325152
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent primary operation on (b)(6) 2019 and presented groin pain since that.X-rays were taken and show movement-loosening of stem.Revision surgery was performed and stem-head was removed.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.The images provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, this case reports a hip revision surgery was performed due to groin pain and movement/loosening of the stem, which was observed on x-ray.Per email communication, there is no consent granted to provide x-rays or surgical reports.The patient impact beyond the revision cannot be determined.No further clinical assessment is warranted at this time.Should clinically relevant documentation become available, the clinical/medical task may be re-evaluated.A review of the 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 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 abnormal motion over time, bone degeneration, fit/sizing, lack of ingrowth and/or traumatic injury.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: UNKNOWN FEMORAL STEM IMPLANT
• Common Device Name: PRSTHSS,HP,SM-CONSTRAINED,MTL/CERAMIC/CERAMIC/MTL,CMNTD OR UNCE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10558257
• Report Number: 1020279-2020-04722
• Device Sequence Number: 2779391
• Product Code: MRA
• UDI-Device Identifier: 00885556498644
• UDI-Public: 00885556498644
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P150030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2021

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 Model Number: 71325152
• Device Catalogue Number: 71325152
• Device Lot Number: 17DT86528
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 08/24/2020; 09/17/2021
• Initial Report FDA Received Date: 09/20/2020
• Supplement Report FDA Received Date: 09/22/2020; 09/20/2021
• 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: 71325152 R3 36MM IDUSDELTALINER52MM OD-17DT86528; UNKNOWN FEMORAL HEAD; UNKNOWN R3 IMPLANT; UNKNOWN FEMORAL HEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention