MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Hearing Impairment (1881); Pain (1994); Visual Impairment (2138); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: item: shell with cluster holes porous 58 mm, catalog #: 00875705801, lot #: 63238350; item: liner elevated rim 36 mm, catalog #: 00875201336, lot #: 63145338; item: femoral stem press-fit collarless 12/14 neck taper, catalog #: 00786401420, lot #: 63207151.Udi: (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The manufacturer did not receive x-rays, or other source documents for review.The device history records were reviewed and found to be conforming.An e-mail requesting the additional information was sent on october 09, 2018 to the appropriate representatives.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.(b)(4).

Event Description

It was reported that a patient was implanted with biolox delta, ceramic femoral head, m, 36/0, taper 12/14.Subsequently, the patient is experiencing pain, vision impairment, severe groin pain, weakness, extreme pain near incision, instability, limited mobility, and hearing loss.Additional information has been requested and is currently not available.

Event Description

Investigation results are now available.

Manufacturer Narrative

Investigation results were made available.Concomitant medical products: item: shell with cluster holes porous 58 mm, catalog #: 00875705801, lot #: 63238350.Item: liner elevated rim 36 mm, catalog #: 00875201336, lot #: 63145338.Item: femoral stem press-fit collarless 12/14 neck taper, catalog #: 00786401420, lot #: 63207151.Dhr-review: ref#: (b)(4)lot#: 2924385.Yield: 107.Delivered: 107.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: pain, vision impairment, weakness, instability, limited mobility, and hearing loss.Event description: it was reported patient underwent left hip revision arthroplasty (b)(6) 2018, the biolox head was implanted.Subsequently patient is experiencing pain, vision impairment, severe groin pain, weakness, extreme pain near incision, instability, limited mobility, and hearing loss.Review of received data: according to patient call report, the patient had initial surgery on (b)(6) 2016 with continuum cup, polyethylene liner, cobalt chrome femoral head and tm primary stem.The arthroplasty on (b)(6) 2018 was a revision due to metallosis.The femoral head was revised to the biolox head.Other component remain implanted in patient.No medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Conclusion summary: it was reported that the patient experience pain, vision impairment, severe groin pain, weakness, extreme pain near incision, instability, limited mobility, and hearing loss.The biolox head remain implanted.No information about whether any further treatment was done.Neither medical records, surgical note nor x-ray images of the revision surgery were received.Patient's adherence to rehabilitation protocol is unknown.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The association of reported vision impairment, hearing loss and weakness to the product is unclear.The limited mobility could be cause by the severe pain experienced by the patient, but pain could not be related to a single specific failure mode.Also, the cause of instability could not be analyzed due to lack of medical records and information.Therefore, due to significant lack of information, we were not able to identify a specific root cause for this issue.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).Note: this is a split case with zimmer inc., warsaw reference number (b)(4).Note: the event of revision surgery is captured in (b)(4).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7955071
• MDR Text Key: 123357166
• Report Number: 0009613350-2018-01064
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

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: 00-8775-036-02
• Device Lot Number: 2924385
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 91