MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71335552
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/16/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference: (b)(4).
Event or Problem Description
It was reported that on (b)(6) 2015, the patient suffered from pain in the hip, which was treated with unspecified medication and is ongoing.Readmission of the patient to the hospital was required on (b)(6) 2015.Hip was never revised.The primary surgery was on (b)(6) 2011 for osteoarthritis.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, approximately 3.5 years post implantation the study subject required an unspecified medication therapy due to mild pain in the contralateral (non-study, right) tha (ae#2).Reportedly, the pain was ongoing/unresolved and patient was re-admitted to the hospital approximately 7-8 months post initial complaints; however, the patient was ¿never revised¿, there was no intervention planned and the patient completed the study.Reportedly, no further information is available.Based on the information provided, the root cause and patient impact beyond the reported mild contralateral tha pain treated with unspecified medication therapy and non-serious hospitalization could not be concluded, as no further intervention or revision was planned and the patient reportedly completed the study.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of the manufacturing records 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 batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 3 HOLE ACET SHELL 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11240510
• Report Number: 1020279-2021-00689
• Device Sequence Number: 14468571
• Product Code: MBL
• UDI-Device Identifier: 03596010598240
• UDI-Public: 03596010598240
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (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): 07/07/2021

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: 07/21/2021
• Device Model Number: 71335552
• Device Catalogue Number: 71335552
• Device Lot Number: 11GM11129
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEAD 76539165, LOT 11HT09746; LINER 71331752, LOT 11HT09821; STEM 71306613, LOT 11DM12655; HEAD 76539165, LOT 11HT09746; LINER 71331752, LOT 11HT09821; STEM 71306613, LOT 11DM12655
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR
• Patient Weight: 80