MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEM HD 36/-3MM; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number N/A

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

Patient Problems Edema (1820); Pain (1994); Swelling (2091)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Concomitant medical devices: medical product: g7 osseoti 4 hole shell 54mm f, catalog #: 110010245, lot #: 6725596; medical product: echo b-mtrc mp fp so 11, catalog #: 193011, lot #: 995030; medical product: g7 vit e neutral lnr 36mm f, catalog #: 30103606, lot #: 64319477.The investigation is in process.Once the investigation has been completed, a supplemental mdr will be submitted.Product remains implanted.

Event Description

It was reported that a patient underwent an initial right hip procedure on (b)(6) 2020.Subsequently on (b)(6) 2020 was seen in physician office and diagnosed with iliopsoas tendonitis and treated.Patient remains implanted.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Summary: as the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaints reported with these item and lot combination.A review of the complaint database over the last 3 years has found 1 similar complaint reported with the item.No trends were identified.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Risk assessment: the event reports it was reported that a patient underwent an initial right hip procedure on (b)(6) 2020.Subsequently on (b)(6) 2020 was seen in physician office and diagnosed with iliopsoas tendonitis and treated.Patient remains implanted.Risk management report documents the estimated residual risk associated with the reported event.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.The reported event states it was reported that a patient underwent an initial right hip procedure on (b)(6) 2020.Subsequently on (b)(6) 2020 was seen in physician office and diagnosed with iliopsoas tendonitis and treated.In the above risk file, pain is considered harm with a severity level of 3 for a number of hazards defined as moderate, which is described in the severity table as: 3: moderate prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.The outcome of the reported event (medical intervention) is considered to be within the severity of the rmf.If further information regarding the root cause of the reported event are provided risk should be re-assessed.

Event Description

It was reported that a patient underwent an initial right hip procedure on (b)(6) 2020.Subsequently on (b)(6) 2020 was seen in physician office and diagnosed with iliopsoas tendonitis and treated.Patient remains implanted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: medical records received: on reviewing medical records received the correct event date of intervention is (b)(6) 2020.Patient information: patient name: (b)(6).Patient age: 59 years.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right hip procedure on (b)(6) 2020.Subsequently on (b)(6) 2020 was seen in physician office and diagnosed with iliopsoas tendonitis and treated.Patient remains implanted.

• Brand Name: DELTA CERAMIC FEM HD 36/-3MM
• Type of Device: CERAMIC FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10625219
• MDR Text Key: 209762691
• Report Number: 3002806535-2020-00438
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K131684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/24/2020

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 Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 650-0660
• Device Lot Number: 3030546
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 12/01/2020; 12/23/2020
• Supplement Dates FDA Received: 12/18/2020; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 71