MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 54F; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Code Available (3191)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign county: (b)(6).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.

Event Description

It was reported the surgeon was implanting the g7 cup and it was 'sticking' to the acetabulum.After multiple strikes to the impaction handle it continued to be unsuccessful.Upon removing the cup it was noticed that black residue from the implant was embedded in the patient.It was noted this was washed out, the implant was changed to one size bigger.After the implant was removed it was washed in the sterilizing department and more notable black residue continued to come off.There was a delay of 45 mins.Washing out the wound, re reaming and new cup placement.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi# (b)(4).Reported event was confirmed by product return.Visual examination of the returned product identified no visible damages.When brushed with finger debris did fall from the outside radius.The device was submitted for further analysis.The analysis determined the debris on the g7 shell pps surface showed c, o, ca, p, na, s, and mg as foreign elements.Debris on the pps surface of the g7 shell sample appears to be biological contamination, which could be from various potential contaminants including biological soft tissue and bone, bone cement (calcium phosphate-based), and other dried biological fluids.Eds analysis of the debris-free area on the g7 shell sample surface showed that the elemental composition was consistent with ti-6al-4v alloy, which is the porous plasma spray (pps) material.Review of the device history records identified no deviations or anomalies during manufacturing.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.

Event Description

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

• Brand Name: G7 PPS LTD ACET SHELL 54F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8770049
• MDR Text Key: 150370261
• Report Number: 0001825034-2019-02913
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000664
• Device Lot Number: 6522295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 10/10/2019
• Supplement Dates FDA Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN STEM
• Patient Outcome(s): Other