MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN SYNERGY HIP STEM UNCEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Device Markings/Labelling Problem (2911); Migration (4003)

Patient Problems Bone Fracture(s) (1870); Joint Dislocation (2374); Malunion of Bone (4529)

Event Type  Injury  

Event Description

It was reported that, during a thr surgery, the patient suffered an intraoperative fracture at the mid plane of the femur.A synergy cementless stem was implanted along with other competitor's implants (stryker).The synergy stem was said to be compatible with these other competitor implants, but when trying to match them the surgery was complicated by the intraoperative bone fracture, apparently because of the way the s+n implant mismatch or design.The surgery was completed with the same device, but it is unknown if there was any delay.Also, when reviewing the operative report, it was noticed that the synergy stem could not be properly identified as it did not have any lot number (off label), it seems like an adulterate medical device.A revision surgery was later performed because the femur did not heal properly (malunion) after the intraoperative fracture that occurred in the primary hip surgery, and this caused the femoral and acetabular component to become subsidence, loose and dislocated.The patient current health status is unknown.Further information is unavailable.

Manufacturer Narrative

H10: internal complaint reference:(b)(4).

Manufacturer Narrative

The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the information was obtained from medwatch; therefore, supporting clinical/medical records are not available.However, a procedural variance is the likely clinical root cause of the reported intraoperative fracture, as it¿s noted fracture occurred while trying to match mixed manufacturer components.As well, the mismatch components are the likely clinical root cause of the reported subsidence, looseness, dislocation and subsequent revision.The patient impact was the revision.A review made by the quality engineering team revealed that, the allegation of the part not having a laser marking can not be verified due the lack of a photo and the part not being returned.All stem are required to have a laser mark on them per print.There are multiple checks within our manufacturing process that check to ensure every stem is properly laser etched.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file, prior actions and product prints could not be performed.A review of the instructions for use documents for total hip systems revealed in warnings and precautions that the surgeon should be thoroughly familiar with the implants, instruments, and surgical procedure prior to performing surgery.Certain insertion techniques may be different than those known for conventional hip systems, and are specifically designed to avoid potential implant failures.It is important to not mix components from different manufacturers unless specially approved by the manufacturer of the components.Failure to comply may result in implant failure and revision surgery.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should the device 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: UNKNOWN SYNERGY HIP STEM UNCEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 18558014
• MDR Text Key: 333439633
• Report Number: 1020279-2024-00209
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/19/2024
• 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): Required Intervention; Other
• Patient Age: 59 YR