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 Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on an acetabulum.Further information is unknown yet.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no medical documents were received for investigation.Therefore no medical assessment can be performed.A review of the manufacturing records for the listed batches did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batches for the same failure mode.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• 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: 8643494
• Report Number: 1020279-2019-02055
• Device Sequence Number: 3236248
• Product Code: MBL
• UDI-Device Identifier: 03596010598257
• UDI-Public: 03596010598257
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

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 Expiration Date: 09/27/2023
• Device Catalogue Number: 71335554
• Device Lot Number: 13JM19498
• Initial Date Received by Manufacturer: 05/04/2019
• Supplement Date Received by Manufacturer: 05/04/2019
• Initial Report FDA Received Date: 05/27/2019
• Supplement Report FDA Received Date: 10/31/2019
• 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