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

Model Number	71335554
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Post Operative Wound Infection (2446)
Date of Event	01/08/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference #: (b)(4).
Event or Problem Description
'us legal" it was reported that the patient suffered from a surgical site infection in her right hip 12 days after a primary right hip arthroplasty was performed on (b)(6) 2010.As reported, the area of incision line reddened and was warm to touch.Small amount of clear yellow drainage from incision was noticed.The patient was treated with antibiotic therapy.The issue was resolved, and the outcome of the patient was positive.
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the redness and warmth of the incision line and small amount of clear yellow drainage is consistent with the reported surgical site infection.However, with the information provided the clinical root cause cannot be confirmed.Additionally, there is no evidence that the reported event is related to the implant.It was reported the issue was resolved.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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of instructions for use, revealed that infection, both early, post-operative superficial and early, post-operative has been identified in potential complications associated with total hip arthroplasty surgery, primary or revision section.A review of the sterilization records revealed the batch was sterilized within normal parameters.A historical review concluded that there are no prior actions related to this product and event.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 are not limited to contamination, patient reaction, and post-operative healing issue.The contribution of the device to the reported event could not be corroborated.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.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the redness and warmth of the incision line and small amount of clear yellow drainage is consistent with the reported surgical site infection.However, with the information provided the clinical root cause cannot be confirmed.Additionally, there is no evidence that the reported event is related to the implant.It was reported the issue was resolved.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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for hip systems revealed that infection, both early, post-operative superficial and early, post-operative have been identified as potential complications associated with total hip arthroplasty surgery, primary or revision.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the sterilization records revealed the batch was sterilized within normal parameters.A historical review concluded that there are no prior actions related to this product and event.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 are not limited to contamination, patient reaction, and post-operative healing issue.The contribution of the device to the reported event could not be corroborated.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 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13483220
• Report Number: 1020279-2022-00568
• Device Sequence Number: 14793192
• Product Code: MBL
• UDI-Device Identifier: 03596010598257
• UDI-Public: 03596010598257
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2020
• Device Model Number: 71335554
• Device Catalogue Number: 71335554
• Device Lot Number: 10JM07945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 03/16/2022; 06/29/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/17/2022; 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71309114/SYN POR PLUS HA HO STEM SZ 14; 71332754/R3 0 DEG XLPE ACET LNR 36MM X 54MM; 71343600/OXINIUM FEM HD 12/14 36 MM +0; ANTIBIOTICS; ANTIBIOTICS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Female