MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X35 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number: 00-8757-056-02, lot number: 62466930, brand name: continuum shell.Catalog number: 00-8751-012-36, lot number: 62874474, brand name: hxpe liner.Catalog number: 00-8777-036-02, lot number: 2826143, brand name: biolox head.Catalog number: 00-6250-065-40, lot number: 631718014, brand name: trilogy screw.Catalog number: 00-6250-065-25, lot number: 63176656, brand name: trilogy screw.Catalog number: 65-7711-009-20, lot number: 60707596, brand name: m/l taper stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated by mfr: device not returned for evaluation.

Event Description

It was reported that during a revision surgery , one of the fixation screws broke and was left implanted in the patients acetabulum.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  d4: (b)(4).Medical records were provided and reviewed by a health care professional.Review of the available records identified that 8 years post implantation patient experienced pain, elevated cobalt and chromium levels.Metallosis and pseudotumor were confirmed upon joint entry,corrosion was also noted on the stem¿s trunnion and femoral head.Patient underwent a revision surgery due to these complications.During the revision procedure, the locking ring was slightly bent and did not lock properly, so the acetabular cup was removed and during implantation of the new shell, the screw broke and was left inside the acetabulum.Reported event was confirmed by review of medical records provided.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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 6.5X35 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: 8735765
• MDR Text Key: 149230720
• Report Number: 0002648920-2019-00463
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

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: 00625006535
• Device Lot Number: 62959152
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 10/28/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Other