MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 40MM 12/14 SHORT+0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	71346004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Medical device site infection (4845)
Date of Event	03/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery of his right tha system (unknown product) on (b)(6) 2020 due to periprosthetic joint infection, and right total hip arthroplasty with multiple dislocations.During the revision surgery, the whole primary tha system was explanted and replaced with a redapt modular shell with a redapt stem.As reported, on (b)(6) 2020, the patient suffered from instability following right revision tha and periprosthetic joint infection and was revised again.During this second revision surgery, the femoral head, and the acetabular liner were explanted.There is no further information at this time.The current state of health of the patient is unknown.
Additional Manufacturer Narrative
H10: internal reference number: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication identified through the review of clinical evidence from post market clinical data collection activities that includes reference to the use of a smith+nephew product.The reported issue(s) relate 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 conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
Additional information: date of event (b3).

• Brand Name: BIOLOX DELTA HEAD 40MM 12/14 SHORT+0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-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: 20203020
• Report Number: 1020279-2024-01817
• Device Sequence Number: 20501932
• Product Code: LZO
• UDI-Device Identifier: 03596010656711
• UDI-Public: 3596010656711
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K100412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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 Catalogue Number: 71346004
• Device Lot Number: UNKNOWN
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 71332530 / REF SPHER HEAD SCREW 30MM; 71332535 / REF SPHER HEAD SCREW 35MM; 71338680 / R3 0 DEG XLPE ACET LNR 40MM X 58MM; 71338689 / R3 20 DEG XLPE LNR 40MM ID X 60 OD; 71352360 / REDAPT MODULAR SHELL 60MM; 71354503 / REDAPT LOCKING SCREW 20MM; 71354731 / REDAPT SLVLS MONO STEM 240MM SZ 23 HO
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 95 KG