MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF ALL POLY 32ID 49OD XLPE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71358034
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on literature review "acute acetabular protrusion: the hardinge approach for implant removal and one-stage hip reconstruction¿, one (1) patient after a tka surgery on the left hip due to acute pelvic penetration of the acetabular shell, sustained three (3) dislocations during simple maneuvers (getting out of bed and sitting on the toilet) due to stemmed from an issue with the soft tissue tension.Patient required revision surgery in which the acetabular cup was changed to a constrained liner which was cemented into the cage.Since this revision, there have been no further dislocations, and the patient is using a zimmer frame for walking while awaiting tha on the opposite side.No further information is available.
Additional Manufacturer Narrative
Internal reference number: (b)(4).H10: this complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources 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.Mencia mm, cruz pph, lewis s, harnanan d.Acute acetabular protrusion: the hardinge approach for implant removal and one-stage hip reconstruction.Ortop traumatol rehabil.2023 oct 31;25(5):259-265.Doi: 10.5604/01.3001.0053.9674.Pmid: 38088100.
Event or Problem Description
It was reported that on literature review "acute acetabular protrusion: the hardinge approach for implant removal and one-stage hip reconstruction¿, one (1) patient after a tka surgery on the left hip on (b)(6) 2022 due to acute pelvic penetration of the acetabular shell, sustained three (3) dislocations during simple maneuvers (getting out of bed and sitting on the toilet) due to stemmed from an issue with the soft tissue tension.Patient required revision surgery on (b)(6) 2022 in which the acetabular cup was changed to a constrained liner which was cemented into the cage.Since this revision, there have been no further dislocations, and the patient is using a zimmer frame for walking while awaiting tha on the opposite side.No further information is available.

• Brand Name: REF ALL POLY 32ID 49OD XLPE
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 19448660
• Report Number: 1020279-2024-01060
• Device Sequence Number: 18269736
• Product Code: JDI
• UDI-Device Identifier: 03596010474247
• UDI-Public: 03596010474247
• Combination Product (Y/N): N
• Initial Reporter Country: TD
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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: Health Professional
• Device Catalogue Number: 71358034
• Device Lot Number: 18BT98795
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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: 71303200/COCR 12/14 FEM HEAD 32 + 0.; 71337059/CONT REINF RING 59/55.; UNKN CONTOUR ACET RING IMPL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male