MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 32/0MM T1; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number N/A

Device Problems Positioning Failure (1158); Fitting Problem (2183); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Medical product: g7 bispherical shell 56f, catalog #: 110017334, lot #: 6607500.Medical product: tprlc 133 t1 pps so 12x144mm, catalog #: 51-103120, lot #: 6663782.Medical product: g7 neutral e1 liner 32mm f, catalog #: 010000850, lot #: 6657095.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00166.(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the liner was not seating properly.Liner was removed, and a new liner was placed.No delay of the procedure was reported.Not known impact or consequences to the patient or the user.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g4, g7, h1, h2, h3, h4, h6, h10.G3: report source, foreign - event occurred in netherlands.D11: medical product: g7 bispherical shell 56f, catalog #: 110017334, lot #: 6607500.Medical product: tprlc 133 t1 pps so 12x144mm, catalog #: 51-103120, lot #: 6663782.Medical product: g7 neutral e1 liner 32mm f, catalog #: 010000850, lot #: 6657095.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00166-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history (liner has been discarded).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 items.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: cmp contains allegation of liner not seating.There are no details provided suggesting any issue with either the femoral head or shell and these remain implanted.The liner is part of associated complaint (b)(4).No risk assessment can be conducted as there is no indication that either the cup or femoral head have presented a hazard/hazardous situation.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported that the liner was not seating properly.Liner was removed, and a new liner was placed.Implanted liner: model: 010000850, lot: 6657095.No delay of the procedure was reported.Not known impact or consequences to the patient or the user.

• Brand Name: DELTA CER FEM HD 32/0MM T1
• 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: 9863348
• MDR Text Key: 196564988
• Report Number: 3002806535-2020-00165
• Device Sequence Number: 1
• Product Code: LPH
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1162
• Device Lot Number: 2019072437
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEEH10
• Patient Age: 65 YR
• Patient Weight: 75