MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL 40/+7, TAPER 12/14

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: zimmer biomet osseoti acetabular shell, size 64 outer diameter, catalog no#:unknown, lot#:unknown.Zimmer biomet acetabular liner for an osseoti cup, highly cross-linked polyethylene with an outer diameter 40, standard, catalog no#:unknown, lot#:unknown.Acetabular screws, 2, catalog no#:unknown, lot#:unknown.Therapy date : (b)(6) 2018.The manufacturer did not receive x-rays for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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
Patient was implanted on the right side and underwent a revision surgery due to scar tissue and repeated instability after dislocation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay updated and additional information.Review of received data: the patient presented the clinic with adverse local tissue reaction with a cobalt level of 18 and chromium of 13 that had been trending up.Post 1st revision surgery the patient twice underwent closed reduction for dislocation.Second closed reduction proved challenging with significant effort required to reduce the hip.With this history patient increased the risk for repeat instability.Hence the patient was revised post two closed reduction.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.Product compatibility couldn't be performed since only one item number is available.Dhr review: dhr review couldn't be performed since lot# is unavailable.Conclusion summary: it was reported that the product was implanted on (b)(6) 2018 and revised on (b)(6) 2018 due to scar tissue, repeated instability after dislocation.Patient was treated twice with closed reduction previously.In vivo time of the device 75 days.First revision for durom cup is captured under (b)(4).Left side durom cup case is captured under (b)(4).The investigation results did not identify a non-conformance or a complaint out of box (coob).However, 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: BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL 40/+7, TAPER 12/14
• Common Device Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9102446
• Report Number: 0009613350-2019-00570
• Device Sequence Number: 1971994
• Product Code: LZO
• UDI-Device Identifier: 00889024430426
• UDI-Public: 00889024430426
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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 Model Number: N/A
• Device Catalogue Number: 00-8775-040-04
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 03/12/2020
• 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