MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71335556
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a potential cup loosening in right hip.
Additional Manufacturer Narrative
The associated r3 3 hole acetabular shell was not returned for evaluation.Therefore, no product analysis could be performed.However, device details were provided.Thus, our investigation including the manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batch which did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.There is no information that would suggest the implanted device failed to meet specifications.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A clinical evaluation noted that based of the sales rep report, the surgeon felt that the cup did not achieve fixation and loosened, however, the reason why is unclear.Therefore, the root cause of the reported loosening cannot be determined.The impact to the patient beyond the revision cannot be determined.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: R3 3 HOLE ACET SHELL 56MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8470340
• Report Number: 1020279-2019-01308
• Device Sequence Number: 19226386
• Product Code: MBL
• UDI-Device Identifier: 03596010598264
• UDI-Public: 03596010598264
• Combination Product (Y/N): N
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2019

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 Catalogue Number: 71335556
• Device Lot Number: 17JW12779
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 08/23/2019
• 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
• Patient Age: 68 YR
• Patient Weight: 83