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
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Codes	Inflammation (1932); Loss of Range of Motion (2032); Tissue Damage (2104); Joint Dislocation (2374)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: LINER STANDARD 3.5 MM OFFSET 36 MM I.D.
• Common Device Name: 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
• Report Number: 0002648920-2020-00449
• Device Sequence Number: 3557889
• Product Code: LPH
• UDI-Device Identifier: 00889024123755
• UDI-Public: (01)00889024123755(17)230630(10)64093516
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K002960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 73