MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 32/+3MM T1; HIP PROTHESIS

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Concomitant medical products: associated products will be reported under medwatch facility warsaw biomet.Medical product: arcos con sz b std 70mm, catalog #: 11-301322 lot # 624570, medical product: arcos 15x150mm spl tpr dist, catalog #: 11-300815, lot #: 137490.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
Event or Problem Description
The patient underwent a hip revision procedure due to migration.
Event or Problem Description
It was reported that a patient underwent an initial knee arthroplasty on an unknown day in (b)(6) 2019.Subsequently, a revision procedure due to migration was performed on (b)(6) 2020.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in united kingdom.D11: associated products will be reported under medwatch facility warsaw biomet.Medical product: arcos con sz b std 70mm, catalog #: 11-301322, lot # 624570; medical product: arcos 15x150mm spl tpr dist, catalog #: 11-300815, lot #: 137490.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 complaint reported with the item 650-1161.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 revision due to migration / implant subsided.As stated in the zper form, the arcos hip subsided resulting in revision due to migration.This issue is investigated under linked complaint (b)(4).As there is no indication that the ceramic head is part of the migration issue, a risk assessment cannot be conducted at this time.If further information regarding the root cause of the reported event are provided risk should be re-assessed.Corrective action taken: no corrective action required at this time.Preventive action taken: no preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DELTA CER FEM HD 32/+3MM T1
• Common Device Name: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9915335
• Report Number: 3002806535-2020-00201
• Device Sequence Number: 701526
• Product Code: LPH
• UDI-Device Identifier: 00887868271557
• UDI-Public: 00887868271557
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1161
• Device Lot Number: 2016110787
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention