MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 58MM; PROSTHESIS, HIP, SEMI-CONS, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71331858
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/01/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was re admitted on the hospital due to pain, he was treated with medication.
Additional Manufacturer Narrative
It was reported that the patient was re-admitted to the hospital due to pain.The affected synergy porous stem, r3 acetabular insert, r3 no hole coated shell, oxinium femoral head, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts 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 products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.It was communicated that this adverse event has been resolved with medications.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Possible causes could include but are not limited to traumatic injury, joint tightness, material in use or patient reaction.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: R3 0 HOLE ACET SHELL 58MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONS, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9530812
• Report Number: 1020279-2019-04635
• Device Sequence Number: 2695643
• Product Code: MBL
• UDI-Device Identifier: 03596010597625
• UDI-Public: 03596010597625
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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: Lay User/Patient
• Device Expiration Date: 11/11/2018
• Device Model Number: 71331858
• Device Catalogue Number: 71331858
• Device Lot Number: 08LM08214
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 05/27/2020
• 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: Hospitalization
• Patient Age: 76 YR
• Patient Weight: 77