MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROTASUL, S30 HEAD, M, 32/0, TAPER 12/14; HIP PROSTHESIS

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem Joint Dislocation (2374)

Event Date 05/02/2023

Event Type  Injury  

Event Description

It was reported that patient underwent an initial hip procedure and approximately six months later, the patient was revised due to dislocation.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Desc: g7 neutral e1 liner 32mm d; item#: 010000848; lot#: 6631170.New zealand.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.

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.A review of the device manufacturing records cannot be performed without product identification.The device is used for treatment.Medical records were not provided.With the available information, a definitive root cause cannot be determined.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: PROTASUL, S30 HEAD, M, 32/0, TAPER 12/14
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 17117592
• MDR Text Key: 317068194
• Report Number: 0009613350-2023-00217
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024164024
• UDI-Public: (01)00889024164024
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• 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: 30.32.06
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female