MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14; HIP IMPLANT

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Unequal Limb Length (4534)

Event Date 06/07/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: item #: 00771100610 femoral stem 12/14 neck taper plasma sprayed press-fit cementless.Size 6 standard offset reduced neck length -lot 62528353.Item #110010242 g7 osseoti 3 hole shell 48mm c lot-7069585.Item #30103203 32mm i.D.Size c neutral liner lot -65233890.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 will be submitted.

Event Description

It was reported that there was an initial total left hip arthroplasty which required a revision the very next day due to issues with size mismatching.Approximately 6 months post-revision the patient reported bilateral hip pain with left hip being greater than the right, and an inability to walk up or down stairs.Patient was prescribed aqua therapy but has yet to start.Approximately 2 years post-revision, the patient underwent a spinal cord surgery for unknown reasons.During a follow-up appointment for this procedure approximately 1 week later, the patient reported 100% pain relief.No further allegations have been reported.Due diligence is in progress for this complaint; to date no additional information has been received.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14
• Type of Device: HIP IMPLANT
• 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: 18923541
• MDR Text Key: 337897590
• Report Number: 0009613350-2024-00099
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430327
• UDI-Public: (01)00889024430327(17)310617(10)3073984
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00877503202
• Device Lot Number: 3073984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White