MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71335556
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that after a thr surgery performed on (b)(6) 2021, the patient experienced a periprosthetic infection; this adverse event was treated by a revision surgery on (b)(6) 2025, during which one biolox delta ce ball head 12/14 36l, one r3 36mm id intl dlt cer lnr 56mm, one r3 3 hole acet shell 56mm, and one polarstem stem std ti/ha 4 non-cem were explanted.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H10: additional information in d10.H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.A review of the production orders did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.For the acetabular shell, a review of complaint history revealed a similar event for the listed part number 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.For the stem, liner, and femoral head, a review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of the instructions for use documents for total hip systems revealed that infection¿both early post-operative superficial and early post-operative deep wound infection, as well as late periprosthetic infection¿has been identified as a potential complication associated with total hip arthroplasty surgery, primary or revision.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and events.A review of the sterilization records revealed the batches were sterilized within normal parameters.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include injury, patient condition, and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should the devices 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 56MM
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22203956
• Report Number: 1020279-2025-01071
• Device Sequence Number: 15175451
• Product Code: MBL
• UDI-Device Identifier: 03596010598264
• UDI-Public: 3596010598264
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K211176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 71335556
• Device Lot Number: 21EW03838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2021
• 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: 71331756 / LOT 21FT51913; 75007450 / LOT C2123906; 75100467 / LOT C2131563
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 55 YR
• Patient Sex: Unknown