MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14; HIP PROTHESIS

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)

Event Date 11/06/2023

Event Type  Injury  

Event Description

It was reported that revision was needed five years post implantation due to polyethylene wear of the acetabular component, resulting in 3 hip dislocations and pain due to acetabular component deteriorating.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

Cmp-(b)(4).D10: 32mm i.D.Size jj neutral liner use with 54mm o.D.Size jj shell item #00885101132 lot#63368562 54mm o.D.Size jj porous uncemented with cluster holes shell use with jj liners item #00875705401 lot #64041843 femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 11 standard offset item #00771101100 lot #63872857 bone screw self-tapping 6.5 mm dia.25 mm length item #00625006525 lot #63985751 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 mdr will be submitted.

Event Description

No additional information at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14
• Type of Device: HIP PROTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18701562
• MDR Text Key: 335295242
• Report Number: 0009613350-2024-00040
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• 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: 00877503201
• Device Lot Number: 2898765
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 86 KG