MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PFM-REV DISTAL PART 18X200; HIP PROSTHESIS

Model Number N/A

Device Problems Material Separation (1562); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 05/10/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision surgery due to loosening of the pin.Because the pin was loose, a side hole had to be drilled in order to remove the distal prosthesis, causing a delay of 30 minutes.All devices were successfully removed.No further outcome reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Concomitant medical products: medical devices.Proximal stem; item# 01.00073.075 ; lot# 2356077, unknown femoral head; item# unknown; lot# unknown, unknown liner; item#unknown; lot# unknown, unknown cup; item# unknown; lot#unknown.Report source: foreign - switzerland.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.The stem was returned for examination with the biolox head still mounted on the taper of the proximal part.Additionally, the shell with the liner still assembled was received.A lot of bone ongrowth is present on the anchoring side of the shell.The liner is generally inconspicuous apart from some scratches on the articulating surface.The stem was received disconnected at the connection between the pin and the distal part.Revision damage in the form of scratches and nicks can be seen on the external surfaces of both proximal and distal parts.On the distal part, some bone ongrowth can be found in the distal half.The biolox head mounted on the taper of the proximal part has metal smears, likely either stemming from the revision surgery or handling afterwards.There is no sign of bone ongrowth on the anchoring surface of the proximal stem.The proximal part and the connection pin are still assembled.There are many apparent signs of abrasion along the face surface of the proximal part, especially along the posteromedial edge.These signs of abrasion matches with those seen on the distal part and likely occurred due to repetitive movement because of the pin loosening from the distal part.On the inside of the distal part, a newly formed ledge can be observed.This ledge likely also formed due to repetitive movement of the loosened pin.On the lateral side, in the proximal region of the distal part, a hole can be seen.It is assumed that drilling was performed through the lateral wall from the outside.Review of the device history records identified no deviations or anomalies during manufacturing with a potential correlation to the reported event.Devices are used for treatment.Based on the radiographs provided, the indicated loosening of the proximal part of the stem with breakout of the connection pin from the distal part can be confirmed.The consultation report states, it was known since 2018 that the pin of the distal part has loosened.This can be confirmed with the received radiographs and the returned retrievals.The wear pattern and newly formed ledge observed on the returned stem indicate that the pin loosened from the distal part, likely causing these observed phenomena through repetitive movement and resulting in the proximal part tipping medially, as seen on the provided radiographic images.Of note is that patient underwent a prior revision surgery, whereby the distal part was left in situ.It is unknown in what condition the pin was during this revision surgery and if this could have potentially contributed to the reported event.However, based on the given information and since neither surgical reports nor any additional radiographic images were provided, we are unable to provide further analysis or draw any definitive conclusions as to why the pin loosened.If any further information is found which would change or alter any conclusions or information, a follow-up report will be filled accordingly.

Event Description

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

• Brand Name: PFM-REV DISTAL PART 18X200
• 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: 14522132
• MDR Text Key: 292810570
• Report Number: 0009613350-2022-00306
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 11/09/2022

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 Expiration Date: 05/15/2006
• Device Model Number: N/A
• Device Catalogue Number: 01.00072.018
• Device Lot Number: 2060440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2001
• 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): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male