MAUDE Adverse Event Report: ZIMMER BIOMET, INC. XLPE LINER STANDARD; PROSTHESIS HIP

Catalog Number 00630505036

Device Problems Corroded (1131); Material Erosion (1214); Device Dislodged or Dislocated (2923)

Patient Problems Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Local Reaction (2035); Tissue Damage (2104); Joint Dislocation (2374); Reaction (2414); Numbness (2415); Ambulation Difficulties (2544); Muscle/Tendon Damage (4532)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part#: 008018036022, femoral head, lot #: 62199447.Part#: 65771100620, femoral stem, lot #: 60418105.Part#: 00620205022, shell, lot #: 62151566.Part#: 00625006540, bone screw, 62211435.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2021 -00017, 0001822565 -2021 -00293.

Event Description

It was reported patient underwent a right hip closed reduction approximately 7 years post implantation due to dislocation and was subsequently revised 5 months later due to pain, elevation metal ion levels, adverse location tissue reaction, and corrosion.The head and liner were revised.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.Medical records were provided and reviewed by a healthcare professional.The following findings were noted.Patient underwent an initial.Patient experienced a dislocation and underwent a closed reduction.Patient was then revised again due to pain, elevated metal ions, altr and corrosion.Dislocation may have been linked to the altr as the joint was lax due to the tissue damage.Turbid fluid, synovial tissue was hypertrophic, and debrided, necrotic debris with pseudotumor.There was a loss of one third of the abductors.Black precipitate was found on the trunnion after removing the head.No damage to locking ring.Device history record (dhr) 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: b5, d5, d9, g3, h2, h3, h6.

Event Description

It was reported patient underwent a left hip closed reduction approximately 7 years post implantation due to dislocation and was subsequently revised 5 months later due to pain, elevation metal ion levels, adverse location tissue reaction, and corrosion.The head and liner were revised.

Manufacturer Narrative

Visual examination of the returned product identified dark debris and a circumferential groove pattern is seen on surface of the conical taper.The poly liner was returned with the rim feature removed.Damage is seen in the inner surface and backside.The stem remains implanted.The head was submitted for further analysis.Analysis determined a consensus modified goldberg score of 4.A score of 4 corresponds to ¿damage over the majority (>50%) of the surface with severe corrosion attack and abundant corrosion debris." root cause unchanged.This complaint was confirmed based on the returned device and medical records.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information to report at this time.

• Brand Name: XLPE LINER STANDARD
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11269699
• MDR Text Key: 230009284
• Report Number: 0001822565-2021-00287
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024123762
• UDI-Public: (01)00889024123762(17)170930(10)62175103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/11/2023

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: 09/30/2017
• Device Catalogue Number: 00630505036
• Device Lot Number: 62175103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 04/20/2021; 06/08/2023; 08/03/2023
• Supplement Dates FDA Received: 04/22/2021; 06/28/2023; 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2012
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 78 KG