MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL POROUS WITH CLUSTER HOLES 56 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Scar Tissue (2060); Tissue Damage (2104); No Code Available (3191)

Event Date 05/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: catalog number: 00801803602 lot number:62435635 brand name: cocr heads; catalog number: 00771101100 lot number: 62449949 brand name: m/l taper stem; catalog number: 00620005622 lot number: 62418072 brand name: acetabular cup; catalog number: 00625006530lot number: 62460730 brand name: bone screw; catalog number: 00625006525 lot number:62483013 brand name: bone screw.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2020-00295, 0001822565-2020-02017, 0001822565-2020-02018.No product was returned; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.During the procedure, white caseating material (form of necrosis w/damaged tissue leaving appearance of soft cheesy substance), and scar tissue was observed in the joint space.The trunnion was worn with a small amount of visible metal wear.Small amount of impingement was noted at the 3 p.M.Position.The poly liner exhibited wear of approximately 1mm depth.The head and liner were replaced with new zimmer biomet products.No other complications/ findings related to the reported event were noted.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.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

It was reported that the patient was revised due to pain, necrosis, tissue damage, elevated metal ion, impingement and implant wear approximately four years post implantation.During the procedure, white caseating material (form of necrosis w/damaged tissue leaving appearance of soft cheesy substance), and scar tissue was observed in the joint space.The trunnion was worn with a small amount of visible metal wear.Small amount of impingement was noted at the 3 p.M.Position.The poly liner exhibited wear of approximately 1mm depth.The head and liner were replaced with new zimmer biomet products.No other complications/ findings related to the reported event were noted.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 56 MM O.D.
• 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
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10492151
• MDR Text Key: 205694260
• Report Number: 0002648920-2020-00397
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2020

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 Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00620005622
• Device Lot Number: 62418072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention