MAUDE Adverse Event Report: ZIMMER GMBH ALLOCLASSIC SL STEM 3 12/14; ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (b)(4) legal department is well trained and passes all information concerning the case to our complaint handling department.Additional concomitant medical products: zimmer mmc, cup, uncemented, 52 mm/44 mm, code j, item# 01.00634.052, lot# 2522499; metasul ldh, head, 44, code j, taper 18/20, item# 01.00181.440, lot# 2400985; metasul ldh, head adapter, m, 0, taper 12/14-18/20, item# 01.00185.146, lot# 2535754.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The device history records were reviewed and found to be conforming.Surgical reports were received and will be reviewed as part of ongoing investigation.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
A patient is pursuing a product liability claim.It was reported that the patient had a revision surgery approximately seven years post implantation due to loosening.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: loosening.Event description: it was reported that the patient had primary left hip implantation surgery on (b)(6) 2010 and was revised on (b)(6) 2017 due to loosening.Review of received data: - primary surgery report dated (b)(6) 2010: preop diagnosis: arthritis left hip operation performed: left thr no abnormalities were observed.Excellent range of motion and stability was achieved during op.-revision surgery report dated (b)(6) 2017: preop diagnosis: loose left total hip stem operation: revision left total hip stem procedure: the stem was found to be loose and removed without difficulty.New stem put into place in a dual mobility, ceramic on plastic.No other issues were observed.Device 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.- surgical technique is reviewed and compared with the primary surgery report, which had no abnormalities observed.Conclusion: patient underwent revision surgery due to stem loosening after 7 years 2 months in-vivo time.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Surgical report of the revision surgery confirms the loosening of the stem.However, there was no x-rays received to comment on the positioning of the components and what happened in-vivo time after implantation.Therefore, based on the available information, we could confirm the reported event, however, an exact root cause could not be determined.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
Please refer to report 0009613350-2018-01185.

• Brand Name: ALLOCLASSIC SL STEM 3 12/14
• Common Device Name: ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8137085
• Report Number: 0009613350-2018-01185
• Device Sequence Number: 18886292
• Product Code: LZO
• UDI-Device Identifier: 00889024481114
• UDI-Public: 00889024481114
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K030373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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: 03/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 00000002843
• Device Lot Number: 2506067
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 06/06/2019
• 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