MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: g7 dual mobility liner 38mm c; catalog #: 110024461; lot#: b232690.Act artic e1 hip brg 28x38mm s44 dia28; catalog#: ep-200144; lot#: unknown.Therapy date: unknown.The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is cmp-(b)(4).

Event Description

Patient was implanted on an unknown side and underwent a revision surgery due to dislocation of the liner after the surgery.

Event Description

Patient was implanted on an unknown side and underwent a revision surgery due to dislocation of the liner after the surgery.

Manufacturer Narrative

Additional information was received on jan 15, 2021.Additional: d6 correction: b4, g4, g7, h10 should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: patient was implanted on (b)(6) 2017 and underwent a revision surgery on an unknown date due to dislodging of the liner from the acetabular cup.Review of received data: due diligence: further follow-up for event clarification was sent and information was received.No medical documents received.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination of the known implants was approved by zimmer biomet.However, the product identification of the stem remains unknown.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: patient was implanted on (b)(6) 2017 and underwent a revision surgery on an unknown date due to dislodging of the liner from the acetabular cup.Based on the investigation the reported event cannot be confirmed.No medical documents were received.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).As the explants have not been received for an investigation, the condition of the head remains unknown.Based on the received information, that the liner dislocated from the acetabular cup, no contribution of the femoral head can be indentified.In conclusion, the most likely root cause of the dislodging of the liner from the acetabular cup is not related to the biolox head.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11129835
• MDR Text Key: 228402124
• Report Number: 0009613350-2021-00001
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430297
• UDI-Public: 00889024430297
• Combination Product (y/n): N
• PMA/PMN Number: K071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2021

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-028-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/25/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 01/15/2021; 02/12/2021
• Supplement Dates FDA Received: 01/27/2021; 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention