MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 36/+3.5, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.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.(b)(4).
Event or Problem Description
Please refer to report 0009613350-2020-00121.
Additional Manufacturer Narrative
Medical product.Bm acet lp dome scw ti s/tap d ia6.5x25mm; catalog no#: 103532; lot#: unknown.Femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 11 standard offset reduced neck length; catalog no#: 00771101110; lot#: unknown.Bone screw self-tapping 6.5 mm dia.20 mm length; catalog no#: 00625006520; lot#: 63042219 shell with cluster holes porous 52 mm o.D.Size ii for use with ii liners; catalog no#: 00875305201; lot#: 64239135.Therapy date: unknown.The manufacturer did receive x-rays, picture and operative reports 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 right side and underwent revision surgery due to dislocation and implant fracture.
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.Event summary: it was reported that the patient had a total hip arthroplasty on the (b)(6) 2019 and had a revision surgery on the (b)(6) 2020 due to implant fracture and dislocation of the ceramic liner.Review of received data : the received doctor¿s notes were reviewed but not relevant to the complaint.The x-ray clearly shows a fracture of the liner with one larger fragment around the stem neck.The intraoperative picture shows the fractured line with the removed tissue.3.Devices analysis: the biolox delta head was received for in-depth examination.The articulation surface of the head is chipped in several locations.Additionally, several coarse scratches are visible on the head articulation surface.Several metallic smears can be seen on the head surface as well as on the bottom surface.The head taper shows a metal transfer from the stem taper as well as several smeared lines.The biolox delta liner is completely broken and could not be returned for in-depth investigation.Review of product documentation: this device is intended for treatment.The compatibility check was performed from (b)(4) 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: it was reported that the patient had a total hip arthroplasty on (b)(6) 2019 and had a revision surgery on (b)(6) 2020 due to implant fracture and dislocation of the ceramic liner.The components were in vivo for approximately 3 months.The visual examination of the ceramic head, the intraoperative picture and the received x-rays confirm the fracture of the liner.The observations made on the ceramic head are concomitance of the liner¿s fracture.It can only be assumed that at one point in time the liner became loose resulting in its fracture.As the liner was not received it is not possible to evaluate if the liner was properly seated in the shell.The quality records were reviewed and showed that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The reported products were reviewed for compatibility and are approved by zimmer biomet.Therefore, the investigation did not identify a non-conformance or a complaint out of box (coob).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).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 36/+3.5, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9835416
• Report Number: 0009613350-2020-00121
• Device Sequence Number: 1212822
• Product Code: LZO
• UDI-Device Identifier: 00889024430372
• UDI-Public: 00889024430372
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-03
• Device Lot Number: 2904679
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 03/25/2020; 04/27/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/20/2020; 04/30/2020
• 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