MAUDE Adverse Event Report: ZIMMER GMBH ALLOCLASSIC, SL STEM, OFFSET, UNCEMENTED, 4, TAPER 12/14; ALLOCLASSIC OFFSET STEM 4

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: alloft-s alloclassic shl 50/hh; catalog no#: 4264 ; lot#: 2256093, metasul, alpha insert, hh/28; catalog no#: 01.00010.408 ; lot#: 2239348, echo b-mtrc mp rp so 7; catalog no#: 19.28.07 ; lot#: 2259082.Therapy date: (b)(6) 2019.The manufacturer received x-rays and other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on the unknown side and underwent revision surgery due to bone fracture.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Event summary: it was reported that a patient underwent a hip revision on the (b)(6) 2019 at (b)(6) hospital where an alloclassic stem was removed and replaced due to a periprosthetic fracture.Review of received data: four x-ray images were received and assessed by nurse group (warsaw).X-rays 1 and 2 are post-second revision against which there is no complaint.X-ray 3 is an immediate post-first revision film as noted by the staple line on the lateral hip.Findings during revision: greater trochanter comminuted, short external rotators detached.Abductors unstable with greater trochanter.Stem, head, liner removed without complication.Trochanteric fracture was stabilized with 6 additional cables.In x-ray 4 are no complications noted.No signs of loosening, radiolucency patients' height: 166.Bmi: 24.7 (centimetres).Significant past medical history: osteoarthritis.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all involved devices are intended for treatment.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Conclusion summary: initial left total hip arthroplasty performed on an unknown date.Subsequently, the patient underwent a revision on (b)(6) 2019 due to periproprosthetic fracture.During the revision, it was noted that the external rotators were detached from the greater trochanter and the abductors were unstable.The stem, head, and liner were removed without the complication and the shell left intact.Cerclage cables were placed around the femur to stabilize the fracture.The investigation results did not identify a non-conformance or a complaint out of box (coob).The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Based on the available information, we were not able to identify an exact root cause for this issue.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
No change to previously reported event.

• Brand Name: ALLOCLASSIC, SL STEM, OFFSET, UNCEMENTED, 4, TAPER 12/14
• Common Device Name: ALLOCLASSIC OFFSET STEM 4
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9361205
• Report Number: 0009613350-2019-00690
• Device Sequence Number: 11414805
• Product Code: LZO
• UDI-Device Identifier: 00889024481312
• UDI-Public: 00889024481312
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033664
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/15/2009
• Device Model Number: N/A
• Device Catalogue Number: 01.00121.040
• Device Lot Number: 2232490
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 03/30/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention