MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN BIRMINGHAM HIP RESURFACING (BHR) IMPL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Ossification (1428); Pain (1994); Discomfort (2330); Implant Pain (4561); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Complaint reference number: (b)(4).

Event Description

It was reported that, after a bhr system had been implanted on an unspecified date, the plaintiff experienced an unspecified adverse event that will be addressed via revision surgery in which the date is still pending.No additional information was provided.

Manufacturer Narrative

H3, h6: it was reported that a revision surgery was performed due to an unspecified adverse event.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, or definite escalation actions review could not be performed.A review of the product¿s instructions for use was not possible due to limited information about the details of the event and device.Without basic part details or an alleged failure mode, no risk file review is possible.No further actions are required at this time.If more information is received, this investigation will be reopened.The requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the unspecified complications.With the limited information provided, the patient impact beyond the reported revision cannot be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

Manufacturer Narrative

Section h3, h6: it was reported that after bhr was performed the patient started to experience slowly progressive pain in his hip as well as squeaking and discomfort.These adverse events were treated via revision surgery where the femoral head and the acetabular component were explanted.No further complications have been reported.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, or definite escalation actions review could not be performed.If more information is received, this investigation will be reopened.The review of the product's current ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed for the cup and head.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions for all cups and heads and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.With the information provided the heterotopic ossification and/or the shallow nature of his acetabular component cannot be ruled out as possible contributing factors to his pain and clinical status.In addition, the clinical root cause for the heterotopic ossification cannot be concluded but some patients can be genetically predisposed, it is a known complication of joint surgeries and is related to the procedure and not the device.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.H6: health effect - clinical code, health effect - impact code and medical device problem code.

Manufacturer Narrative

A2: age or date of birth, b5: describe event or problem, d6: if implanted, give date, d7: if explanted, give date, d11: concomitant medical products and therapy dates h6: health effect - clinical code and medical device problem code.

Event Description

It was reported that after total hip arthroplasty was performed on (b)(6) 2006, the patient started to experience slowly progressive pain in his lip as well as squeaking and discomfort.These adverse events were treated via revision surgery on (b)(6) 2023 were the femoral head and the acetabular component were explanted.No further complications have been reported.

• Brand Name: UNKNOWN BIRMINGHAM HIP RESURFACING (BHR) IMPL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16935672
• MDR Text Key: 315267944
• Report Number: 3005975929-2023-00070
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• 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
• Date Manufacturer Received: 08/10/2023
• 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
• Treatment: UNKN BIRMINGHAM HIP RESURFACING (BHR) HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male