MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF NO HOLE SHELL SZ 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71334152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Failure of Implant (1924)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tha was performed on an unspecified date, the patient experienced a joint capsule infection and the echelon ha std 260 bow s 12 l was broken.This adverse event was solved by a revision surgery on (b)(6) 2021, in which the ref no hole shell sz 52mm, echelon ha std 260 bow s 12 l, oxinium fem hd 12/14 32mm +8 and an unkn reflection liner were explanted.Current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based solely on the component¿s manufacture/expiration dates, the revision was performed at greater than 5 years post implantation.Although late onset infection post-prosthetic implantation is rare, in the absence of the requested medical documentation, clinical factors (and/or source of the infection) which could have contributed to the reported event could not be definitively concluded, and a causal relationship to the reported event could not be confirmed.The patient impact beyond the reported infection, breakage, and revision could not be determined.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 33 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that has been identified as a that infection, both early, post-operative superficial and early, post-operative deep wound infection and late periprosthetic infection has been identified in potential complications associated with total hip arthroplasty surgery, primary or revision section.A review of the risk management file 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 this product and event.Based on the clinical/medical evaluation conclusions, sterilization review was not required.At this time, we have no reason to suspect that the product 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 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: REF NO HOLE SHELL SZ 52MM
• 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: 12847133
• Report Number: 1020279-2021-08244
• Device Sequence Number: 11813539
• Product Code: MBL
• UDI-Device Identifier: 03596010455390
• UDI-Public: 03596010455390
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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: 03/29/2014
• Device Model Number: 71334152
• Device Catalogue Number: 71334152
• Device Lot Number: 04CM16042
• 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: 11/01/2021
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2004
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown