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

Model Number	71331852
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	02/24/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that mri demonstrated mild diffuse fatty infiltration.Right hip aspiration was performed.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.A clinical evaluation indicated that his pain is most likely associated with adverse reaction to his prosthesis; most likely with the modular neck.Elevations in metal ion levels, effusion, and hypertrophy of the synovium are consistent with findings associated with an armd.Without the pre-revision x-rays, it cannot be determined whether the greater trochanter fracture occurred pre-revision, or as a result of using the mallet.Without post-implantation x-rays to determine initial anatomical placement and any micro-motion over time, it cannot be ruled out the undersized femoral component and its varus position as contributory factors; as well as the noted modular neck, which the surgeon suspects as the source for the metal debris.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported reactions cannot be confirmed, nor concluded that the reported clinical reactions were associated with a mal-performance of the implants.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the device history records for the listed batches did not reveal any deviation from the standard manufacturing processes.Factors and/or potential causes that could contribute to the reported event have been identified as undersized femoral component, varus, incorrect materials, and material composition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should the devices or additional information be received, the complaints will be reopened.

• Brand Name: R3 0 HOLE ACET SHELL 52MM
• 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: 9409351
• Report Number: 1020279-2019-04274
• Device Sequence Number: 11504915
• Product Code: MBL
• UDI-Device Identifier: 03596010597595
• UDI-Public: 03596010597595
• Combination Product (Y/N): N
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: 11/18/2021
• Device Model Number: 71331852
• Device Catalogue Number: 71331852
• Device Lot Number: 11LM10890
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 03/26/2020
• 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: Required Intervention
• Patient Age: 68 YR