MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN POLARSTEM CEMENTLESS (TI/HA); PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number UNKN1102402

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Cypres, a., fiquet, a., girardin, p., fitch, d., bauchu, p., bonnard, o., & roy, c.(2019).Long-term outcomes of a dual-mobility cup and cementless triple-taper femoral stem combination in total hip replacement: a multicenter retrospective analysis.Journal of orthopaedic surgery and research, 14(1), 1-6.Doi: doi.Org/10.1186/s13018-019-1436-y.

Event Description

It was reported that on literature review "long-term outcomes of a dual-mobility cup and cementless triple-taper femoral stem combination in total hip replacement: a multicenter retrospective analysis", 4 patients suffered from osteolysis around the stem after a primary thr with the polar system.It was not reported how the adverse events were resolved.The outcome of the patients is unknown.No further information is available.

Manufacturer Narrative

H3, h6: in the literature article of cypres et al.2019 [1], it was reported that, 4 patients suffered from osteolysis around the stem after a primary total hip replacement surgery with the polar system.The devices, used in treatment, were not returned for investigation and the part and batch number of the reported complaint are not known.Therefore, it is not possible to investigate whether the reported devices met manufacturing specification upon release for distribution.The severity and the failure mode are covered through our risk management.A thorough medical investigation could not be performed due to insufficient information.The reported failure mode "osteolysis" is stated as a potential adverse device effect in the hip instruction for use of smith and nephew (lit.No.12.23 ed.03/21).Based on the performed investigations, the failure mode and the relationship between the devices and the reported events cannot be confirmed.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event and it is not possible to perform a review of past corrective actions.No probable cause can be determined and no further actions will be taken to this date.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor the devices for further similar issues.

• Brand Name: UNKNOWN POLARSTEM CEMENTLESS (TI/HA)
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14279773
• MDR Text Key: 290659343
• Report Number: 9613369-2022-00249
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2022

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: UNKN1102402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 06/12/2022
• 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