MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X30 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: 00625006530-bone scr 6.5x30 self-tap-64629272, 010000663- g7 pps ltd acet shell 52e-6554683, 010000857-g7 neutral e1 liner 36mm e-6623355.Two acetabular screw product identifications were reported in conjunction with this event.It is unknown after follow-up attempts which device pushed or pulled through the cup.X-ray report also confirms that only one of the screws extended through the screw hole.The information for the second screw is as follows: item name: bone scr 6.5 x 30 self-tap, catalog number: 00625006530, lot number: 64629272, expiration date: dec 31, 2029 manufacture date: jan 22, 2020.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient¿s acetabular screw was found to have either pulled through the cup or was pushed through the cup post implantation via x-ray.No revision reported at this time.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Lot: 64629272, bone scr 6.5x30 self-tap, d4: udi: (b)(4).Reported event was confirmed via review of radiographs by a health care professional.Review of the available records identified the following: one of the two acetabular fixation screws extends through the screw hole and does not affix the acetabular implant.No other findings related to the reported event were noted.Review of the device history records identified no deviations or anomalies during manufacturing.Supplier's device history records were not reviewed as the receiving inspection report indicated that the hex dimensions, overall length, major diameter and minor diameter of the threads are measured during incoming inspection (sampling plan used).A definitive root cause cannot 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: BONE SCR 6.5X30 SELF-TAP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10420480
• MDR Text Key: 203324817
• Report Number: 0002648920-2020-00382
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

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: 00625006530
• Device Lot Number: 64676705
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Other