MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71335550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr had been performed on (b)(6) 2021, the clinical subject experienced dislocation on the right hip three times: on the day of discharge ((b)(6) 2015) by getting out of the sofa, on (b)(6) 2021 when turning around and on (b)(6) 2021 while standing (the last two were described as a consequence of first dislocation).Every time, the adverse event was addressed via hospitalization and closed reposition on the same dates the dislocations occurred.The issue is resolved.
Additional Manufacturer Narrative
G3, h2, h3, and h6: given the nature of the allegation, 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 information provided, the patient activity (i.E.Low-sofa, twisting motion) is suspect of a lack of maintaining early-post-operative hip precautions and the presence of comorbidities could not be ruled out as potential contributing factors to the reported events; however, the root cause of the dislocations could not be definitively concluded.The patient impact beyond the reported recurrent dislocations and subsequent closed reductions could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation become available in the future, this case may be re-opened/re-assessed.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.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.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.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.A2: patient information available.B7: patient information available.D10: add concomitants.G2: report source update.G4: add 510k code.

• Brand Name: R3 3 HOLE ACET SHELL 50MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12028780
• Report Number: 1020279-2021-05259
• Device Sequence Number: 4257285
• Product Code: MBL
• UDI-Device Identifier: 03596010598233
• UDI-Public: 03596010598233
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71335550
• Device Catalogue Number: 71335550
• Device Lot Number: 20KW18652
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/18/2021
• 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: AFTER 17-MAR-2021 SURGERY, THE PATIENT WAS DISCHAR; OXINIUM FEM HD 12/14 32MM +8/19MM12114; POLARSTEM STEM LAT.TI/HA 2 NON-CEM/B2016035; R3 0 DEG XLPE ACET LNR 32MM X 50MM/20KW18652
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR