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

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling (2091); Tissue Damage (2104); Reaction (2414); Ambulation Difficulties (2544); Inadequate Osseointegration (2646)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 00625006535 bone scr 6.5x35 self-tap lot# 61146379, item# 00620205422 shell porous with cluster holes 54 mm lot# 61091648, item# 00801803602 femoral head sterile product do not resterilize 12/14 taper lot# 61244813, item# 00786401420 femoral stem press-fit collarless 12/14 neck taper standard body extended neck offset size 14 149 mm stem length cementless lot# 61034344.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 03742, 0002648920 - 2019 - 00646, 0001822565 - 2019 - 03740, 0002648920 - 2019 - 00644.

Event Description

It was reported that patient was revised on an unknown date due to cobalt/chromium poisoning, cup detachment, disconnection, creation of metallic debris, and/or loosening, pain, inhibition of the ability to walk, the need for a de-implantation/revision surgery and other injuries including, inter alia, a deformed leg and foot.Attempts to obtain additional information was made; however, none was available.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Investigation is in process and a follow-up mdr will be submitted upon completion.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Lab notes were provided and confirm that patient was experiencing elevated metal ion levels.Additional information does not change the outcome of the previous investigation.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.

Manufacturer Narrative

Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03634.

Event Description

It was reported that patient underwent a left hip revision approximately 10 years post implantation due to pain, limping, elevated metal ion levels.During the surgery, oxidative wear was found on the poly along with significant metallosis, trunnionosis, bursitis, synovitis, and heterotopic ossification.The head and liner were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h6 reported event was unable to be confirmed by review of medical records.Additional information does not change the outcome of the previous investigation.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: 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: 8956918
• MDR Text Key: 156579632
• Report Number: 0002648920-2019-00645
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2018
• Device Model Number: N/A
• Device Catalogue Number: 00625006535
• Device Lot Number: 61152406
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 115