MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN REFLECTION METAL CUP; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Hip Fracture (2349); Joint Dislocation (2374); Inadequate Osseointegration (2646); Insufficient Information (4580)

Event Date 08/09/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Zhou, x., chen, m., yu, w., han, g., ye, j., & zhuang, j.(2020).Uncemented versus cemented total hip arthroplasty for displaced femoral neck fractures in elderly patients with osteoporosis: a retrospective analysis.Journal of international medical research, 48(8), 0300060520944663.Doi: 10.1177/0300060520944663.

Event Description

It was reported that on literature review ""uncemented versus cemented total hip arthroplasty for displaced femoral neck fractures in elderly patients with osteoporosis: a retrospective analysis"", 144 patients had a thr with a reflection cup.Of these, sixteen (16) had a prothesis revision for unknown reasons, twenty three (23) a prothesis loosening, fourteen (14) a periprosthetic fracture and seven(7) presented dislocation.It is unknown how this adverse events were treated.Patients outcome is unknown.No further information is available.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation and the reported events could not be confirmed.The clinical/medical investigation concluded that, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patients outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should clinical documentation become available in the future, a thorough medical assessment may be rendered at that time.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, infection, patients condition, abnormal motion over time, bone degeneration, patients anatomy, abnormal loading of limb, fit/sizing issue, lack of ingrowth, traumatic injury, excessive forces applied to implant and surgical technique.The contribution of the devices to the reported events could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.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: UNKN REFLECTION METAL CUP
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 13863694
• MDR Text Key: 287708485
• Report Number: 1020279-2022-01275
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization