MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL

Model Number	71331852
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that the patient underwent a medical indicated revision surgery on the right hip on (b)(6) 2018.The revision surgery was performed due to dislocation.The shell, head and liner were explanted and replaced with zimmer parts.The index competitor stem remains implanted.The patient underwent a posterior sepsis and pneumonia after this revision surgery, but no s&n implants were involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, reportedly the pain and revision were due to dislocation of the right hip while bending over donning the right shoe.The clinical root cause of the reported dislocation could not be definitively concluded; however, the mixed manufacturer right hip-construct, history of prior right hip dislocation/revision approximately 8 weeks ago, and the patient activity could not be ruled out as a possible contributing factors to the reported events.Of note, the patient does have a contralateral history of revisions x 3 due to dislocations, one notably in 10/2015 during an attempt to don socks.It could not be concluded that the reported clinical findings were associated with a mal-performance of the s+n implants used in the mixed-manufacturer-construct.Patient impact assessed was the dislocation, subsequent pain, ambulation difficulties, and revision which included exploration of the sciatic nerve due to continued foot-drop.Further patient impact could not be determined.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.

• Brand Name: R3 0 HOLE ACET SHELL 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11541080
• Report Number: 1020279-2021-02275
• Device Sequence Number: 14603112
• Product Code: MRA
• UDI-Device Identifier: 03596010597595
• UDI-Public: 03596010597595
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: 06/07/2019
• Device Model Number: 71331852
• Device Catalogue Number: 71331852
• Device Lot Number: 09FM06131
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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
• Patient Age: 71 YR