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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 07/27/2007

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a bhr resurfacing primary surgery had been performed on the patient¿s right hip on (b)(6) 2007, the patient required an immediate washout procedure due to a postoperative hematoma.Additional details regarding this intervention are not known.

Manufacturer Narrative

It was reported that the patient required an immediate washout procedure due to a postoperative hematoma.Additional details regarding this intervention are not known and the devices, used in treatment, are presumed to still be implanted.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.A review of historic escalation actions related to the products and similar complaint events was performed.No prior applicable escalation actions were identified and no further escalation actions are required.A risk management review was performed for the acetabular cup.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 physician¿s note 10 years post implantation noted, ¿he has no history of infection, but he did have a history of an immediate washout for a hematoma several days after the initial surgery.¿ no other documentation regarding this event was provided.With the limited information provided, the clinical root cause of the reported hematoma and subsequent washout cannot be confirmed; however, the hematoma is a known complication of surgery and is related to the procedure and not the device.The patient impact beyond the hematoma and washout cannot be determined.Based on the reported operative notes we can confirm the complaint, however without additional information we cannot further investigate the reported issue.Based on the information provided, the probable root cause is that the issue is not related to the device and seems to have been caused by something other than the device or usage.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.

Manufacturer Narrative

H3, h6: it was reported that the patient required an immediate washout procedure due to a postoperative hematoma.Additional details regarding this intervention are not known and the devices, used in treatment, are presumed to still be implanted.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.A review of historic escalation actions related to the products and similar complaint events was performed.No prior applicable escalation actions were identified and no further escalation actions are required.A risk management review was performed for the acetabular cup.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 physician¿s note 10 years post implantation noted, ¿he has no history of infection, but he did have a history of an immediate washout for a hematoma several days after the initial surgery.¿ no other documentation regarding this event was provided.With the limited information provided, the clinical root cause of the reported hematoma and subsequent washout cannot be confirmed; however, the hematoma is a known complication of surgery and is related to the procedure and not the device.The patient impact beyond the hematoma and washout cannot be determined.Based on the reported operative notes we can confirm the complaint, however without additional information we cannot further investigate the reported issue.Based on the information provided, the probable root cause is that the issue is not related to the device and seems to have been caused by something other than the device or usage.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.

Manufacturer Narrative

H10 - additional information a4 - patient weight b6 - relevant tests b7 - other relevant history.

• Brand Name: UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE)
• 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: 14973824
• MDR Text Key: 295601107
• Report Number: 3005975929-2022-00418
• Device Sequence Number: 1
• Product Code: NXT
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2022
• 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?: Yes
• Date Manufacturer Received: 06/14/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 66 KG