MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 40/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122148

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 04/03/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

Us legal.It was reported that the plaintiff underwent a bhr revision surgery on the left hip on (b)(6) 2019 due to pain, limited mobility, metal staining of the sub-cutaneous bursa tissue, cloudy fluid in the hip joint, cobalt toxicity, and adverse local tissue reaction.The primary left bhr surgery was performed on (b)(6) 2008.The patient current status is unknown.

Manufacturer Narrative

H10.Corrected data in d6b.The device reported here (unkn birmingham hip resurfacing (bhr) cup) was not explanted during the revision surgery, therefore, the explantation date provided in the previous supplemental mdr is not applicable.Internal reference number: (b)(4).

Event Description

It was reported that the plaintiff underwent a bhr revision surgery on the left hip on (b)(6) 2019 due to pain, limited mobility, metal staining of the sub-cutaneous bursa tissue, cloudy fluid in the hip joint, cobalt toxicity, adverse local tissue reaction and mechanical complication of the joint implant.The primary left bhr surgery was performed on (b)(6) 2008.During the revision, the metallic femoral head was explanted, and the system was revised to a tha.The patient was transferred to the recovery room in good condition.

Manufacturer Narrative

H10.Additional information provided in a2, b5, d6b.Internal reference number: (b)(4).

Manufacturer Narrative

H3, h6: it was reported that a left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.Since part/lot details were not received for investigation no thorough manufacturing record review can be performed.If the products or additional information become available in the future, the tasks will be reopened and performed.A risk management review was performed.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.The clinical information provided of the (metal staining of the subcutaneous bursa tissue, cloudy appearing fluid, and synovitis around the margins of the head) may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.Without the return of the devices used in treatment or additional information we cannot advance the investigation or confirm this complaint; our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity, unreasonable stress on replacement system.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

Additional information: d8, g4 (510k).Corrected data: b5, d1, d4 (catalog number & udi), d6a.

Event Description

It was reported that the plaintiff underwent a bhr revision surgery on the left hip on (b)(6) 2019 due to pain, limited mobility, metal staining of the sub-cutaneous bursa tissue, cloudy fluid in the hip joint, cobalt toxicity, adverse local tissue reaction and mechanical complication of the joint implant.The primary left bhr surgery was performed on (b)(6) 2008.During the revision, the metallic femoral head was explanted, and the system was revised to a tha.The patient was transferred to the recovery room in good condition.

Manufacturer Narrative

It was reported that a left hip revision surgery was performed due to pain, limited mobility, metal staining of the sub-cutaneous bursa tissue, cloudy fluid in the hip joint, cobalt toxicity, adverse local tissue reaction and mechanical complication of the joint implant.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the device.A review of historical complaints data was performed using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.No other similar complaints have been identified for acetabular cup.As the device is no longer sold, no action is to be taken.As no device batch number was provided for investigation, manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The review of the current ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.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 related to the product and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.Although the reported pain and cobalt toxicity, and intraoperative findings of metal staining, cloudy appearing fluid, and synovitis may be consistent with the reported metallosis, the clinical root cause of the reported clinical reactions cannot be confirmed with the information provided.It cannot be concluded the reported clinical reactions/event was associated with a mal performance of the implant.The patient impact beyond the reported pain, revision and post-revision convalescence period cannot be determined.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.H11: corrected information in h6 (health effect - clinical code and health effect - impact code).

• Brand Name: ACETABULAR CUP HAP SIZE 40/48
• 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: 13362273
• MDR Text Key: 284519137
• Report Number: 3005975929-2022-00028
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552266
• UDI-Public: 03596010552266
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/28/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 74122148
• Device Catalogue Number: 74122148
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 01/28/2022; 01/28/2022; 03/03/2022; 10/10/2022; 10/27/2022
• Supplement Dates FDA Received: 02/01/2022; 02/01/2022; 03/03/2022; 10/12/2022; 10/29/2022
• 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
• Removal/Correction Number: Z-2746-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 52 YR
• Patient Sex: Female