MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71335554
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that recurrent dislocations on (b)(6) 2017 & (b)(6) 2018 occurred.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, the doctor¿s statement that the patient¿s need for a 3rd revision, to ¿increase the head size and/or mobility¿and without a revision attempt, that certainly she will dislocate at some point again¿ indicates that the likely root cause for her multiple post-revision dislocations is due to an inappropriate head size, or another reason for unexpected joint laxity.To date, there is no indication that the patient has had the 3rd revision performed.No further clinical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: R3 3 HOLE ACET SHELL 54MM
• 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: 8642581
• Report Number: 1020279-2019-02037
• Device Sequence Number: 11173647
• Product Code: MBL
• UDI-Device Identifier: 03596010598257
• UDI-Public: 03596010598257
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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: 71335554
• Device Lot Number: 17BM17380
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 11/04/2019
• 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: 65 YR