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

Catalog Number UNKN1102304

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

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Date 11/21/2019

Event Type  Injury  

Event Description

It was reported that on literature review "excellent midterm survival and functional outcomes of a fully hydroxyapatite-coated cementless stem: first results of a prospective multicenter study", 1 patient underwent a revision surgery where the stem was revised 6 weeks after initial surgery due to unknown reasons.No further information is available.There is no information within the study to determine whether these adverse events occurred in (b)(6) or in (b)(6).

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.

Manufacturer Narrative

H3, h6: in the literature article of cypres et al.2019 [1], it was reported that, 1 patient suffered from bone atrophy after a primary total hip replacement surgery with the polar system.The device, used in treatment, was 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 device 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.A review of the device labelling revealed that the ifu (lit.No.12.23 ed.03/21) states known possible risk factors and side effects in combination with the implantation of a hip prosthesis.Based on the performed investigations, the failure mode and the relationship between the device and the reported event 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.

Manufacturer Narrative

Additional information h6: b22 code added.Internal complaint reference number: (b)(4).

• Brand Name: UNKNOWN POLARCUP SHELL NON-CEMENTED (TI-PLASMA OR 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: 14279770
• MDR Text Key: 290703951
• Report Number: 9613369-2022-00251
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2022

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: UNKN1102304
• 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: 05/27/2022; 07/19/2022
• Supplement Dates FDA Received: 06/21/2022; 07/19/2022
• 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