MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14; BIOLOX DELTA HEAD, 12/14, 32 X 0

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hematoma (1884)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 7.5 extended offset reduced neck length; catalog# : 00771100740; lot# : 64189409.Liner 10 degree elevated rim 32 mm i.D.For use with 50/52/54 mm o.D.Shells; catalog# : 00631005032; lot# : 64225034.Shell porous with cluster holes 52 mm; catalog# : 00620205222; lot# : 64309132.The manufacturer did not receive x-rays for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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

Patient was implanted on the right side and was treated for hematoma and gi bleed which occurred 2 days post operation.

Event Description

No change to previously reported event.

Manufacturer Narrative

Event description: it was reported that product was implanted on (b)(6) 2019 and 2 days post operation patient was treated for hematoma and gi bleed.There was no medical intervention for hematoma.A gastroscopy was performed which ruled out an active gi bleed.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Surgical report: the surgical report has been reviewed, however no conspicuous findings relevant to the reported event have been identified.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 compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was not approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that product was implanted on (b)(6) 2019 and 2 days post operation patient was treated for hematoma and gi bleed.There was no medical intervention for hematoma.A gastroscopy was performed which ruled out an active gi bleed.The investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, 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).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14
• Type of Device: BIOLOX DELTA HEAD, 12/14, 32 X 0
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9409300
• MDR Text Key: 169024565
• Report Number: 0009613350-2019-00764
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430327
• UDI-Public: 00889024430327
• Combination Product (y/n): N
• PMA/PMN Number: K071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• 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: 00-8775-032-02
• Device Lot Number: 2993910
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 82