MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF NO HOLE SHELL SZ 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71334160
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, after a thr surgery performed on (b)(6)2004, the patient experienced a dislocation of the hip.A revision was performed on (b)(6)2024 in order to exchange the reflection implant.The current health status of the patient is unknown.
Additional Manufacturer Narrative
D1: brand name, d2a: common device name, d2b: procode, d4: catalog #, lot #,expiration date, unique identifier (udi) #, d11: concomitant medical products and therapy dates, g5: pma/510(k) #.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, four x-ray images were provided, none were dislocated within the image, in the absence of the requested medical documentation and or clinical factors which could have caused or contributed to the reported event, the definitive clinical root cause could not be definitively concluded, and a causal relationship to the reported event could not be confirmed.Although we cannot rule out the patient¿s bone quality, and trauma/fall as likely contributory factors.Out.Of note, the implant was insitu approximately 20 years prior to the dislocation.The patient's impact beyond the reported revision could not be determined since the patient's health status is unknown.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the shell and the cup, a review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed device.For the femoral head and the hole cover, a review of complaint history revealed similar events for the listed devices over the previous 12 months, but no similar events for the batches based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems reveals in potential complications associated with total hip arthroplasty surgery, primary or revision that looseness of acetabular or femoral components, extraneous bone, penetration of the femoral prosthesis through the shaft of the femur, fracture of the acetabulum, intrapelvic protrusion of acetabular component, femoral impingement, periarticular calcification, and/or excessive reaming may increase the risk of dislocations, subluxation, decreased range of motion, or lengthening or shortening of the femur, which may lead to revision surgery.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.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: REF NO HOLE SHELL SZ 60MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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: 20855959
• Report Number: 1020279-2024-02578
• Device Sequence Number: 8623085
• Product Code: MBL
• UDI-Device Identifier: 03596010455437
• UDI-Public: 3596010455437
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: 71334160
• Device Lot Number: 04LM07031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 12/03/2024; 01/29/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 12/09/2024; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OXINIUM FEM HD 12/14 32MM +0, LOT#:04FM05800.; REF INTERFIT THRD HOLE COVER, LOT#:04BM01520.; REF XLPE 32 20 DEG 58-60 G, LOT#:04KM21324.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown