MAUDE Adverse Event Report: ZIMMER GMBH PROTASUL®, S30 HEAD, S, ø 32/-4, TAPER 12/14; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 04/02/2024

Event Type  Injury  

Event Description

It was reported that patient underwent hip revision approximately 8 years post implantation due to dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).G2: report source 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.

Event Description

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

Manufacturer Narrative

(b)(4).D10: part# 00885101332 - 32mm i.D.Size ll neutral liner use with 58mm o.D.Size ll shell - lot# 62819740.Part# 00875705801 - 58mm o.D.Size ll porous uncemented with cluster holes shell use with ll liners - lot# 63055860.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be 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.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PROTASUL®, S30 HEAD, S, ø 32/-4, TAPER 12/14
• Type of Device: PROSTHESIS, HIP
• 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: 19058231
• MDR Text Key: 339557459
• Report Number: 0009613350-2024-00131
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024508224
• UDI-Public: (01)00889024508224(17)241031(10)2783091
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K183457
• 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: 05/17/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 303205
• Device Lot Number: 2783091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• 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: 32MM I.D. SIZE LL NEUTRAL LINER; 58MM POROUS UNCEMENTED WITH CLUSTER HOLES SHELL; SEE H11.
• Patient Outcome(s): Required Intervention; Hospitalization