MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STEM LATERAL 5 NON-CEMENTED; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 75002758

Device Problem Loss of Osseointegration (2408)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646)

Event Date 09/22/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a thr surgery performed on (b)(6) 2006, a revision surgery on a total hip prosthesis was performed on (b)(6) 2021 to explant the ceramic ceramic insert standard 48/36 that had been fractured for several weeks.The patient complained of pain around the right hip.A loosening of the sl-plus stem lateral 5 non-cemented was noted.Current health status of the patient is unknown.

Manufacturer Narrative

H10: it was reported that, after a thr surgery performed on (b)(6) 2006, a revision surgery on a total hip prosthesis was performed on 22-sep-2021 to explant the ceramic insert standard 48/36 that had been fractured for several weeks ((b)(4)).The patient complained of pain around the right hip.A loosening of the sl-plus stem lateral 5 non-cemented was noted ((b)(4)).Current health status of the patient is unknown.The complaint device sl-plus stem lateral 5 non-cemented, used in treatment, was not returned for investigation hence the product evaluation could not be performed.A review of the batch record revealed no deviations from the standard manufacturing process.A review of the complaint history revealed no additional complaint for the batch in question.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Review of past corrective actions was performed.No further escalation is required.The ifu stated inadequate osseointegration among possible side effects resulting from hip arthroplasty.The medical investigation was performed.The reported pain is consistent with the loosening of the femoral stem and rupture of the ceramic insert.However, with the limited information provided the clinical root cause of the loosening of the femoral stem and rupture of the ceramic insert cannot be confirmed.It should be noted the components were implanted 15 years prior to revision.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.Based on the performed investigations, the reported failure mode could not be confirmed independently since the complaint device was not available for investigation.A relationship between the reported event and the device cannot be confirmed.The reported device met manufacturing specifications upon release for distribution.No probable cause can be determined.This version of the device will be monitored for similar issues.This investigation is considered closed.Should the complaint device become available, the complaint will be reassessed.Internal complaint reference number: (b)(4).

• Brand Name: SL-PLUS STEM LATERAL 5 NON-CEMENTED
• 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: 14626900
• MDR Text Key: 293735434
• Report Number: 9613369-2022-00271
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07611996078053
• UDI-Public: 07611996078053
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2013
• Device Model Number: 75002758
• Device Catalogue Number: 75002758
• Device Lot Number: C0600764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2006
• 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
• Treatment: BIOLOX FORTE CE BALL HEAD 12/14 36M, LOT#:0605.15.; EP-FIT SHELL TI-PLASMA/HA W.SCREW OPT.56, LOT#:060
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 98 KG