MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER STANDARD 3.5 MM OFFSET 36 MM I.D.; PROSTHESIS, HIP

Model Number 6305-50-32

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Inflammation (1932); Loss of Range of Motion (2032); Tissue Damage (2104); Joint Dislocation (2374)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

Cmp (b)(4).Zimmer bioloxa® delta, ceramic femoral head, m, a¸ 32/0, taper 12/14 cat#00877503202 zimmer shell porous with cluster holes 52 mm cat#00620205222 lot#63835268 the device will not be returned for analysis due to the device being discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.

Event Description

It was reported a patient underwent an initial right tha.Subsequently, the patient was revised approximately 2 years later due to peri-prosthetic fracture (patient fell and landed on right hip), impingement, synovitis, rom limited mobility, subsidence, subluxation, and wear.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.The following sections were updated/corrected.Updated: h2; h3; h6.Medical records were provided and reviewed by a healthcare professional.Review of the records identified the following: the patient fell and was revised due to peri-prosthetic fracture, impingement, synovitis, rom limited mobility, subsidence, subluxation, and wear.A comminuted fracture of the proximal femur was noted.The stem was impacted into the femur and rotated in severe anteversion.The femoral head was noted to be mildly subluxed.Metal debris was noted lining the capsule and bursal area.The liner was noted to be damaged posteriorly from the neck of the femur and it did impinge and wore through the plastic on the edge and generated some metal debris.The shell remained implanted, all other components replaced.Review of the device history records identified no deviations or anomalies during manufacturing.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: LINER STANDARD 3.5 MM OFFSET 36 MM I.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
• MDR Report Key: 10649853
• MDR Text Key: 210438438
• Report Number: 0002648920-2020-00449
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024123755
• UDI-Public: (01)00889024123755(17)230630(10)64093516
• Combination Product (y/n): N
• PMA/PMN Number: K002960
• 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: 01/05/2021

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: 06/30/2023
• Device Model Number: 6305-50-32
• Device Catalogue Number: 00630505036
• Device Lot Number: 64093516
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 73